Health product recall

Medline Kits containing Surgical Gowns, Packs and Drapes

Last updated

Summary

Product
Medline Kits containing Surgical Gowns, Packs and Drapes
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalogue number

Simple Neck Dissection

21BBP023

DYNJ47481C

Ortho - ACL Pack

25CBJ143

DYNJ51249B

Ortho - ACL Pack

25ABK343

DYNJ51249B

Ortho - ACL Pack

24FBF369

DYNJ51249B

Ortho - ACL Pack

24LBN605

DYNJ51249B

Liver-Kidney Pack LF

20LBW807

DYNJ38251B

Vasc - AAA - LF

23ABI719

DYNJ41839C

Cardio - Open Heart Bypass-LF

23ABB558

DYNJ41835G

Hej-ENS Carnio Tumeur-LF

22OBC403

DYNJ56840B

Ensemble Gyne Laparotomie-LF

23DBD093

DYNJ47550C

Hip Pack

22LBR516

DYNJ41692F

New Tissue Retrieval MH

More than 10 numbers, contact manufacturer.

DYNJ903849B

New Tissue Retrieval MH

More than 10 numbers, contact manufacturer.

DYNJ903849C

Total Knee-LF

22DBO761

DYNJ905304A

Hip Pinning Pack

23KBA130

DYNJ69563A

DOS BJC - LF

22LBR516

DYNJ41666A

Gen. Surgery Laparoscopic-LF

More than 10 numbers, contact manufacturer.

DYNJ86668

Gen. Surgery Laparoscopic-LF

More than 10 numbers, contact manufacturer.

DYNJ905297B

Ortho-Knee-LF

23FLA163

DYNJ905304A

Laparoscopic Chole WRM-LF

25FBT117

DYNJ41956D

Laparoscopic Chole WRM-LF

24BBO282

DYNJ41956D

Laparoscopic Chole WRM-LF

24JBF282

DYNJ41956D

Laparoscopic Chole WRM-LF

24JBM896

DYNJ41956D

Laparoscopic Chole WRM-LF

24KBG868

DYNJ41956D

Laparoscopic Chole WRM-LF

24HBE001

DYNJ41956D

Laparoscopic Chole WRM-LF

24DBU735

DYNJ41956D

Laparoscopic Chole WRM-LF

23LBK420

DYNJ41956D

Laparoscopic Chole WRM-LF

23KBB750

DYNJ41956D

ENT - Minor ENT Pack-LF

21IBQ696

DYNJ56840B

ENT - Minor ENT Pack-LF

21IBQ699

DYNJ56840B

ENT - Minor ENT Pack-LF

22GBJ777

DYNJ56840B

Arthroscopy PK R5HC

23GBJ533

DYNJ27524G

Ensemble Chirurgie Pieds-Ortho

25JBW661

DYNJ88795

Ensemble Chirurgie Pieds-Ortho

25CBS371

DYNJ88795

Ensemble Chirurgie Pieds-Ortho

25BBO562

DYNJ88795

Custom Cardiovascular Procedure Kit/Tray

21BBB532

DYNJ32435I

Cysto Pack

21JBN450

DYNJ50946A

Delivery Pack

25GBN237

DYNJ37331C

Laminectomy PK LF

22IBW059

DYNJ41857C

Cardiac Cath No Mnfld Rvhs-LF

24BBG775

DYNJ47684C

Ortho Extremity GGH-LF

24ABF458

DYNJ41808C

Ortho Extremity GGH-LF

23KBT722

DYNJ41808C

Ortho Extremity GGH-LF

24DBJ076

DYNJ41808C

Sick Kids General Custom Split

24JBB041

SPTPCD10005

Issue

Medline identified calibration issues linked to the equipment used to sterilize the recalled products, impacting the sterility assurance level. This creates the potential for a non-sterile device to be placed within the sterile field, or be used within a sterile procedure. This could lead to contamination and/or patient infection. These products are found within kits and customers are being asked to quarantine affected kit lot numbers and will be provided over-labels.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - General and plastic surgery
Companies

Medline Industries, LP

Three Lakes Drive, Northfield, Illinois, United States, 60093

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-81588

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