Cook Incorporated: COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Cook Incorporated
- Product
- COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
- Reason / hazard
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution.
- Recall initiated
- 2026-03-05
- Code info
- Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)261005(10)NS15690755, Lot Number NS15690755; Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)260426(10)NS15408335, Lot Number NS15408335.
- Product quantity
- 20 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bloomington
- State
- IN
- Country
- United States
- Event id
- 98495
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