Medical Device Kits Recalled for Non-Sterile Surgical Components
Medline Industries is recalling See DocMan custom convenience kits that contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 48,655 units were distributed worldwide.
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: This is an FDA Class II recall for medical devices with potential high-risk contamination (endotoxin) in non-sterile surgical components. Although no illnesses or injuries are reported in the source material, the recall addresses a risk-of-harm product where sterility is critical for patient safety.
Plain-English summary
Medline Industries, LP is recalling See DocMan custom convenience kits due to the inclusion of non-sterile Codman Surgical Patties and Surgical Strips. These components have the potential for endotoxin contamination.
Approximately 48,655 units have been distributed worldwide, including to the United States, the United Arab Emirates, and Canada. The recall affects multiple product reference numbers and lot numbers spanning from 2019 through 2024.
Consumers and healthcare providers should discontinue use of these kits immediately. Contact Medline Industries or your supplier for instructions regarding return or replacement of affected units. Non-sterile surgical materials pose a risk of infection in clinical settings.
The recalled product
- Product
- See DocMan
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- 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 CDS981185B
- UDI/DI 10884389647141 (EA) 40884389647142 (CS)
- Lot Numbers: 19CDB151
- 19DDD096
- 19FDA612
- 19IDA540
- 19LDB150
- 20BDA647
- 20DDB481
- 20IDA733
- 20LDA459
- 2) REF CDS983087G
- UDI/DI 10193489237351 (EA) 40193489237352 (CS)
- Lot Numbers: 21LBS976
- 3) REF CDS983302G
- UDI/DI 10888277753181 (EA) 40888277753182 (CS)
- Lot Numbers: 19JDB741
- 4) REF CDS983302I
- UDI/DI 10193489425659 (EA) 40193489425650 (CS)
- Lot Numbers: 23FDA273
Distribution
Distributed nationwide across the United States.
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