Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Reason: Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Z-0557-2025December 4, 2024Farnborough
AVID Medical, Inc.
Class IIOngoing
Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01
Reason: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical sit...
Z-0442-2025November 20, 2024Toano, VA
AVID Medical, Inc.
Class IIOngoing
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
Reason: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical sit...
Z-0443-2025November 20, 2024Toano, VA
AVID Medical, Inc.
Class IIOngoing
Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
Reason: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical sit...
Z-0413-2025November 20, 2024Toano, VA
AVID Medical, Inc.
Class IIOngoing
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
Reason: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical sit...
Z-0453-2025November 20, 2024Toano, VA
AVID Medical, Inc.
Class IIOngoing
Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10
Reason: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical sit...
Z-0429-2025November 20, 2024Toano, VA
AVID Medical, Inc.
Class IIOngoing
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
Reason: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical sit...
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BRE...
Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal ...
Z-0156-2025October 30, 2024Northfield, IL
American Contract Systems, Inc.
Class IIOngoing
Pacemaker, COPM11B; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3244-2024October 2, 2024Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
PACEMAKER PACK, SLCV01J; Medical convenience kit
Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confi...
Z-3226-2024October 2, 2024Kansas City, MO
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL...
Reason: XXX
Z-2995-2024September 18, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4)...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Z-3037-2024September 18, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J;...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Z-2993-2024September 18, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G ; 2) ZALE OTOLOGY CDS, Pack Number CDS983181D ; 3) BGMC GENERAL LAPAROSCOPY PK-LF, Pack Number DYNJ0664747...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Z-3001-2024September 18, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020; 3) 6" FEMORAL ARTERIAL LINE KIT, Pack Number ART245B...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma...
Z-2768-2024September 4, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, ...
Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Z-2701-2024August 28, 2024Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b....
Reason: Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Reason: Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
Z-1695-2024May 8, 2024Sylmar, CA
MEDLINE INDUSTRIES, LP - Northfield
Class IOngoing
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G,...
Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile...
Z-1096-2024March 6, 2024Northfield, IL
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
Boston Scientific Corporation
Class IIOngoing
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ...
Reason: The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
Z-0673-2024January 17, 2024Saint Paul, MN
Cardinal Health 200, LLC
Class IIOngoing
Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular....
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) ...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2166-2023July 26, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.