See DocMan Surgical Kits Recalled for Non-Sterile Surgical Patties and Strips
Medline Industries is recalling See DocMan custom convenience kits containing non-sterile Codman Surgical Patties and Strips due to potential endotoxin contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of surgical devices with potential for endotoxin contamination. This meets the Score 3 criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
See DocMan custom convenience surgical kits manufactured by Medline Industries are being recalled because they contain non-sterile Codman Surgical Patties and Surgical Strips. These components may be contaminated with endotoxins, which are bacterial toxins that can cause adverse reactions if the kits are used in medical procedures.
The recalled kits have been distributed worldwide, including to the United States, the United Arab Emirates, and Canada. The recall involves 205,360 units across multiple product reference numbers and lot numbers.
Healthcare facilities and consumers who have received these kits should stop using them immediately and contact Medline Industries for information on returns and replacement of non-contaminated products.
The recalled product
- Product
- See DocMan
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical kits
- Hazard
- non-sterile
- endotoxin
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) REF CDS780162AA
- UDI/DI 10193489262049 (EA) 40193489262040 (CS)
- Lot Numbers: 20BBO888
- 20BBQ352
- 20FBR735
- 2) REF CDS780162AB
- UDI/DI 10193489338447 (EA) 40193489338448 (CS)
- Lot Numbers: 20GBF853
- 3) REF CDS780162AC
- UDI/DI 10193489383911 (EA) 40193489383912 (CS)
- Lot Numbers: 20HBE537
- 20IBB263
- 20JBB811
- 20KBA268
- 20LBM232
- 21ABA833
- 4) REF CDS780162AD
- UDI/DI 10193489498950 (EA) 40193489498951 (CS)
- Lot Numbers: 21ABU170
- 21BBQ045
Distribution
Distributed nationwide across the United States.
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