CanadaMedline Industries, LP surgical kits containing gowns, packs and drapes are affected; affected items are specific kit types with the listed lot/serial and catalogue numbers (for example Simple Neck Dissection, Lot 21BBP023, Cat. DYNJ47481C and multiple Ortho, Cardio, Vascular, laparoscopic and other packs with the catalogue numbers and lot numbers shown in the notice). Medline identified sterilization equipment calibration issues that may compromise sterility and could lead to contamination or patient infection; customers are asked to quarantine affected kit lot numbers and will be provided over‑labels, and to contact the manufacturer for additional information.
What's being recalled
Companies: Medline Industries, LP, Three Lakes Drive, Northfield, Illinois, United States, 60093.
How to identify it
Affected products: Simple Neck Dissection; Lot or serial number: 21BBP023; Model or catalogue number: DYNJ47481C
Affected products: Ortho - ACL Pack; Lot or serial number: 25CBJ143; Model or catalogue number: DYNJ51249B
Affected products: Ortho - ACL Pack; Lot or serial number: 25ABK343; Model or catalogue number: DYNJ51249B
Affected products: Ortho - ACL Pack; Lot or serial number: 24FBF369; Model or catalogue number: DYNJ51249B
Affected products: Ortho - ACL Pack; Lot or serial number: 24LBN605; Model or catalogue number: DYNJ51249B
Affected products: Liver-Kidney Pack LF; Lot or serial number: 20LBW807; Model or catalogue number: DYNJ38251B
Affected products: Vasc - AAA - LF; Lot or serial number: 23ABI719; Model or catalogue number: DYNJ41839C
Affected products: Cardio - Open Heart Bypass-LF; Lot or serial number: 23ABB558; Model or catalogue number: DYNJ41835G
Affected products: Hej-ENS Carnio Tumeur-LF; Lot or serial number: 22OBC403; Model or catalogue number: DYNJ56840B
Affected products: Ensemble Gyne Laparotomie-LF; Lot or serial number: 23DBD093; Model or catalogue number: DYNJ47550C
Affected products: Hip Pack; Lot or serial number: 22LBR516; Model or catalogue number: DYNJ41692F
Affected products: New Tissue Retrieval MH; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: DYNJ903849B
Affected products: New Tissue Retrieval MH; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: DYNJ903849C
Affected products: Total Knee-LF; Lot or serial number: 22DBO761; Model or catalogue number: DYNJ905304A
Affected products: Hip Pinning Pack; Lot or serial number: 23KBA130; Model or catalogue number: DYNJ69563A
Affected products: DOS BJC - LF; Lot or serial number: 22LBR516; Model or catalogue number: DYNJ41666A
Affected products: Gen. Surgery Laparoscopic-LF; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: DYNJ86668
Affected products: Gen. Surgery Laparoscopic-LF; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: DYNJ905297B
Affected products: Ortho-Knee-LF; Lot or serial number: 23FLA163; Model or catalogue number: DYNJ905304A
Affected products: Laparoscopic Chole WRM-LF; Lot or serial number: 25FBT117; Model or catalogue number: DYNJ41956D
Affected products: Laparoscopic Chole WRM-LF; Lot or serial number: 24BBO282; Model or catalogue number: DYNJ41956D
Affected products: Laparoscopic Chole WRM-LF; Lot or serial number: 24JBF282; Model or catalogue number: DYNJ41956D
Affected products: Laparoscopic Chole WRM-LF; Lot or serial number: 24JBM896; Model or catalogue number: DYNJ41956D
Affected products: Laparoscopic Chole WRM-LF; Lot or serial number: 24KBG868; Model or catalogue number: DYNJ41956D
Affected products: Laparoscopic Chole WRM-LF; Lot or serial number: 24HBE001; Model or catalogue number: DYNJ41956D
Affected products: Laparoscopic Chole WRM-LF; Lot or serial number: 24DBU735; Model or catalogue number: DYNJ41956D
Affected products: Laparoscopic Chole WRM-LF; Lot or serial number: 23LBK420; Model or catalogue number: DYNJ41956D
Affected products: Laparoscopic Chole WRM-LF; Lot or serial number: 23KBB750; Model or catalogue number: DYNJ41956D
Affected products: ENT - Minor ENT Pack-LF; Lot or serial number: 21IBQ696; Model or catalogue number: DYNJ56840B
Affected products: ENT - Minor ENT Pack-LF; Lot or serial number: 21IBQ699; Model or catalogue number: DYNJ56840B
Affected products: ENT - Minor ENT Pack-LF; Lot or serial number: 22GBJ777; Model or catalogue number: DYNJ56840B
Affected products: Arthroscopy PK R5HC; Lot or serial number: 23GBJ533; Model or catalogue number: DYNJ27524G
Affected products: Ensemble Chirurgie Pieds-Ortho; Lot or serial number: 25JBW661; Model or catalogue number: DYNJ88795
Affected products: Ensemble Chirurgie Pieds-Ortho; Lot or serial number: 25CBS371; Model or catalogue number: DYNJ88795
Affected products: Ensemble Chirurgie Pieds-Ortho; Lot or serial number: 25BBO562; Model or catalogue number: DYNJ88795
Affected products: Custom Cardiovascular Procedure Kit/Tray; Lot or serial number: 21BBB532; Model or catalogue number: DYNJ32435I
Affected products: Cysto Pack; Lot or serial number: 21JBN450; Model or catalogue number: DYNJ50946A
Affected products: Delivery Pack; Lot or serial number: 25GBN237; Model or catalogue number: DYNJ37331C
Affected products: Laminectomy PK LF; Lot or serial number: 22IBW059; Model or catalogue number: DYNJ41857C
Affected products: Cardiac Cath No Mnfld Rvhs-LF; Lot or serial number: 24BBG775; Model or catalogue number: DYNJ47684C
Affected products: Ortho Extremity GGH-LF; Lot or serial number: 24ABF458; Model or catalogue number: DYNJ41808C
Affected products: Ortho Extremity GGH-LF; Lot or serial number: 23KBT722; Model or catalogue number: DYNJ41808C
Affected products: Ortho Extremity GGH-LF; Lot or serial number: 24DBJ076; Model or catalogue number: DYNJ41808C
Affected products: Sick Kids General Custom Split; Lot or serial number: 24JBB041; Model or catalogue number: SPTPCD10005
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States