Medline Kits containing Surgical Gowns, Packs and Drapes
Brand(s)
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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