Cook Medical multipurpose drainage catheters carry overstated expiration dates
Cook Medical is recalling a Multipurpose Drainage Catheter because affected lots were labeled with expiration dates that exceed the product's true shelf life. 20 units are affected.
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 where an overstated expiry date can lead to use of a sterile device beyond its validated shelf life, a risk of harm with no injuries reported.
Plain-English summary
Cook Medical is recalling the Multipurpose Drainage Catheter, reference part number ULT8.5-38-25-P-CLMS-8-RH-FS, order number G29775. The action covers 20 units.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life of the product. A catheter carrying an overstated expiry can be held and used after the point at which its sterility and performance were validated. The FDA classified the action as Class II.
Distribution was worldwide. The catheters are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the reference part number and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Cook Medical.
The recalled product
- Product
- COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
- Manufacturer
- Cook Incorporated
- Affected units
- 20
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 (5)
- Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS
- UDI (01)00827002297753(17)261005(10)NS15690755
- Lot Number NS15690755
- UDI (01)00827002297753(17)260426(10)NS15408335
- Lot Number NS15408335.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
Same manufacturer · Cook Incorporated
See all →- CriticalAurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
- CriticalCook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
- SevereBeacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
- HighCook Medical tracheostomy introducer sets labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
- HighCook Medical pneumothorax tray labeled with an overstated expiration date
FDA (Devices) · 2026-04-15
Same hazard · expiration date error
See all →- HighMentor Texas LP Recalls Expired Luer Lok Syringes Due to Distribution Error
FDA (Devices) · 2026-07-08
- HighCook Medical chest tube tray labeled with an overstated expiration date
FDA (Devices) · 2026-04-15
- HighCook Medical Spectrum central venous catheter trays carry overstated expiration dates
FDA (Devices) · 2026-04-15
- HighCook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
- HighCook Medical extubation set labeled with an overstated expiration date
FDA (Devices) · 2026-04-15