Recall MonitorHealth Products
Medline Kits containing Surgical Gowns, Packs and Drapes
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use, Health products - Medical devices - General and plastic surgery
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
Recall class: Type II
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.