Medical Procedure Packs Recalled Due to Defective Components
Cardinal Health is recalling surgical procedure packs due to defective components. The recall affects 13,351 packs distributed across the US 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 affecting surgical procedure packs used in patient care. While no illnesses or injuries have been reported, these are medical devices whose component defects could pose potential harm during surgical procedures.
Plain-English summary
Cardinal Health 200, LLC is recalling Presource Portacath Packs (Cat. SANV1PIFSB, Lot #67711) and Presource Bone Marrow Harvest Packs (Cat. SAN12BHGT1, Lot #13526) because they contain recalled components including equipment drapes, table covers, and surgical room turnover kits.
The recalled packs were distributed to medical facilities in 34 US states, the District of Columbia, and Canada. A total of 13,351 packs are affected by this recall.
No illnesses or injuries have been reported in connection with these recalled packs. Medical facilities that received these products should immediately discontinue use and contact Cardinal Health for replacement instructions or return procedures.
The recalled product
- Product
- Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and (2) Presource Bone Marrow Harvest Pack, Cat. SAN12BHGT1, Medstar Georgtown University H, Sterile.
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 13,351
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 (6)
- (1) Cat. SANV1PIFSB - Lot #67711
- Exp. 3/1/2026
- UDI-DI 10195594532048
- and (2) Cat. SAN12BHGT1 - Lot #13526
- Exp. 3/1/2024
- UDI-DI 10197106202715.
Distribution
Part of a larger recall action
This product is one of 10 recalled by Cardinal Health 200, LLC 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.
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