Cardinal Health Recalls Surgical Procedure Packs With Recalled Components
Cardinal Health is recalling 13,351 procedure packs used in surgical procedures because they contain recalled components. The affected packs were distributed nationwide and in 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 recall of surgical procedure packs with no reported illnesses or injuries in the source. These are medical devices used in surgical procedures where component failures could pose risks. Per the rubric, this is classified as a risk-of-harm product where injury has not yet been reported, supporting a High severity rating.
Plain-English summary
Cardinal Health 200, LLC is recalling 13,351 procedure packs designated as Presource PBDS Cat. PLMHCSBHF, which are used in surgical procedures including C-section deliveries. The procedure packs contain equipment drapes, table covers, and surgical room turnover (SRT) kits that have been identified as recalled components.
The recalled packs were distributed nationwide across 33 US states, Washington DC, Hawaii, and the country of Canada. The affected lots are Lot #81461 with expiration dates of June 1, 2024 and September 1, 2024 (UDI-DI: 10195594542795).
Healthcare facilities and surgical centers that have received these procedure packs should review their inventory against the lot numbers and expiration dates. Any affected packs should be removed from use. Facilities should contact Cardinal Health for instructions regarding return or disposal of the recalled products.
The recalled product
- Product
- Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- device-defect
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 (3)
- Lot #81461
- Exp. 6/1/2024 and Exp. 9/1/2024
- UDI-DI 10195594542795.
Distribution
Distributed nationwide across the United States.
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