Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 38 of 63
Customed, Inc
Class II Terminated
Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1450-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1448-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1454-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1436-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1462-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1451-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1399-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1404-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1414-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1488-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1482-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1463-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate woun...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1472-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002193 SHOULDER ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds,...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1444-2016 April 20, 2016 Fajardo, PR
PMBS, LLC
Class II Terminated
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
Reason: Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
Z-1266-2016 April 6, 2016 Stockton, NJ
Medtronic Navigation, Inc.
Class II Terminated
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide hol...
Reason: Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.
Z-1234-2016 March 30, 2016 Louisville, CO
Novadaq Technologies Inc.
Class II Terminated
PINPOINT Endoscopic Fluorescence Imaging System
Reason: It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light gu...
Z-1032-2016 March 9, 2016 Burnaby, N/A
Stryker Howmedica Osteonics Corp.
Class II Terminated
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Reason: The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and shoul...
Z-0855-2016 March 2, 2016 Mahwah, NJ
Orthofix, Inc
Class II Terminated
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
Reason: There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value ma...
Z-0797-2016 February 17, 2016 Lewisville, TX
Innovasis, Inc
Class II Terminated
Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilizatio...
Reason: Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Z-0662-2016 January 27, 2016 Salt Lake City, UT
Arthrosurface, Inc.
Class II Terminated
Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
Reason: An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.
Z-0475-2016 December 30, 2015 Franklin, MA
Utah Medical Products, Inc
Class II Terminated
Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape,...
Reason: Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where the seal between the T...
Z-0233-2016 November 18, 2015 Midvale, UT
DeRoyal Industries Inc
Class II Terminated
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08D...
Reason: Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant du...
Z-0241-2016 November 18, 2015 Powell, TN
DeRoyal Industries Inc
Class II Terminated
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATR...
Reason: Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant du...
Z-0240-2016 November 18, 2015 Powell, TN
Innovative Sterlization Technologies LLC
Class II Terminated
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Reason: The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.
Z-0153-2016 October 28, 2015 Dayton, OH