1,565 results found for sterilization
Page 10 of 63
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA4...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0820-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0816-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0824-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE P...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0830-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0831-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) D...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0828-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0823-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number ...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0826-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; ...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0817-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0821-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0818-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower E...
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0833-2024February 7, 2024Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting docu...
Z-0832-2024February 7, 2024Temple Terrace, FL
Olympus Corporation of the Americas
Class IIOngoing
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Reason: The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-ste...
Z-0716-2024January 24, 2024Center Valley, PA
Steris Corporation
Class IIOngoing
V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages Model: SU2014-001
Reason: Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. This may allow a pink dye/residue to appear on the Bandage Scissors and/or sterilizat...
Z-0737-2024January 24, 2024Mentor, OH
Olympus Corporation of the Americas
Class IIOngoing
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Reason: The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-ste...
Z-0717-2024January 24, 2024Center Valley, PA
Atrium Medical Corporation
Class IIOngoing
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Reason: A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadverte...
Z-0621-2024January 3, 2024Merrimack, NH
Atrium Medical Corporation
Class IIOngoing
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Reason: A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Z-0484-2024December 13, 2023Merrimack, NH
Atrium Medical Corporation
Class IIOngoing
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Reason: Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation...
Z-0486-2024December 13, 2023Merrimack, NH
Atrium Medical Corporation
Class IIOngoing
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Reason: Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation...
Z-0485-2024December 13, 2023Merrimack, NH
Olympus Corporation of the Americas
Class IIOngoing
EVIS EXERA III Gastrointestinal Videoscope
Reason: Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Z-0288-2024November 15, 2023Center Valley, PA
American Contract Systems, Inc.
Class IIOngoing
LAVH, REF BBLV21C
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0172-2024November 1, 2023Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Pediatric Urology Wolson Pack, REF BPPU55A
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0181-2024November 1, 2023Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Breast Plastics Pack, REF BBPL20D
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...
Z-0173-2024November 1, 2023Temple Terrace, FL
American Contract Systems, Inc.
Class IIOngoing
Sub Q Recorder Pack, REF BPRC87A
Reason: During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected ...