Medline Medical Procedure Kits Recalled for Non-Sterile Component Contamination
Medline Industries is recalling 2,664 custom medical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The affected kits were distributed in the US, UAE, and Canada.
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 medical device recall involving non-sterile surgical components with potential for endotoxin contamination. No illnesses or injuries have been reported, meeting the High severity threshold for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling three types of custom medical procedure kits: ENSEMBLE RACHIS-LF (REF DYNJ47568B), UROLOGY ROBOTIC (REF DYNJ55555D), and KIT, SPINE LH (REF DYNJ906448A). A total of 2,664 units have been distributed.
The kits are being recalled because they contain non-sterile Codman Surgical Patties & Surgical Strips that have the potential for endotoxin contamination. The products were distributed in the United States, United Arab Emirates, and Canada.
Customers who have received these kits should cease use and contact Medline Industries for information on returns or replacement.
The recalled product
- Product
- Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
- endotoxin-contamination
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 DYNJ47568B
- UDI/DI 10193489846058 (EA) 40193489846059 (CS)
- Lot Numbers: 21EBP877
- 21EBP891
- 21GBW057
- 21GBW059
- 21KBG927
- 21WBA306
- 22ABO417
- 22EBE351
- 22FBX502
- 22FBY332
- 22IBJ001
- 22LBA177
- 23ABD998
- 23BBE825
- 23CBI861
- 23EBO916
- 23FBQ324
- 23GBN118
Distribution
Distributed nationwide across the United States.
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