Medline CISION Sterile Surgical Blades Recalled for Sterile Packaging Breach Risk
Medline Industries is recalling CISION Sterile Blades used in surgical procedures due to potential for the blade to puncture the sterile outer packaging, breaching sterility. No injuries reported.
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 a risk-of-harm product (surgical instrument with compromised sterility packaging). No illnesses or injuries reported, and the hazard is theoretical, meeting the rubric criterion for score 3.
Plain-English summary
Medline Industries, LP is recalling CISION Sterile Blades, surgical instruments used in medical procedures requiring tissue separation. The recalled products include multiple blade sizes (No. 10, 11, 12, 15, 20, 21, and 22) made of carbon steel or stainless steel, with approximately 76,053 units distributed.
The blades are being recalled because there is potential for the blade to puncture the outer foil layer of the sterile packaging, creating a breach in the sterile barrier. This could compromise the sterility of the instrument if used in surgical procedures.
The affected products were distributed nationwide to healthcare facilities in 30 states including Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Michigan, New York, Ohio, Pennsylvania, Texas, and others. Specific lot numbers are identified by item number in the FDA recall notice.
Healthcare providers and facilities with these recalled products should stop using the affected lots immediately. Contact Medline Industries for guidance on returns and replacement instruments. No injuries or infections have been reported to date.
The recalled product
- Product
- Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterile-packaging-breach
- contamination-risk
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)
- a. Item Number: CISION10CS
- Box UDI/GTIN: 30193489090103
- Case UDI/GTIN: 20193489090106
- Lot Numbers: Y01853
- Z00300
- Z02246
- Z02288
- Z02290
- Z02416
- Z02473
- b. Item Number: CISION10CSR
- Box UDI/GTIN: 30193489090110
- Case UDI/GTIN: 20193489090113
- Lot Numbers: Z02259
- Z02436
- Z00381
- Z02202
- Z02563
- Z02261
- Z02435
Distribution
Distributed nationwide across the United States.
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