Presource PBDS Surgical Procedure Packs Subject to Nationwide Recall
Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs distributed nationwide in the US and Canada. The specific reason for the recall was not disclosed in the available FDA notice.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall with no reported illnesses, injuries, or deaths. The lack of reported adverse events and undisclosed hazard make this a precautionary recall typical of moderate severity.
Plain-English summary
Cardinal Health 200, LLC is recalling 13,351 Presource PBDS surgical procedure packs across 72 different catalog numbers used in orthopedic and spinal surgical procedures. The specific reason for the recall was not provided in the available FDA notice.
The affected packs were distributed nationwide across the United States in Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and West Virginia, as well as in Canada. No deaths or injuries have been reported in connection with this recall.
Hospitals and surgical centers should identify recalled packs using the catalog numbers and lot numbers specified in FDA Recall Number Z-0091-2024 and follow Cardinal Health's recall instructions for appropriate handling and replacement of affected items.
The recalled product
- Product
- Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5
- Manufacturer
- Cardinal Health 200, LLC
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)
- (1) Cat. PN33BPCR2 - Lot #986971
- Exp. 9/1/2024
- UDI-DI 10197106132319
- (2) Cat. POCGANA11 - Lot #936749
- Exp. 8/1/2024
- UDI-DI 10197106027257
- (3) Cat. PODKHAKAB - Lot #18022
- Exp. 5/1/2024
- UDI-DI 10888439441819
- (4) Cat. POMHKAESV - Lot #967651
- Exp. 12/1/2023
- UDI-DI 10195594543341
- (5) Cat. POMHLEE11 - Lot #39223
- UDI-DI 10197106255087
- (6) Cat. POMVTHANLE - Lot #926669
- Exp. 9/1/2023
- UDI-DI 10195594471781
- (7) Cat. POVMPAB11 - Lot #951430
- UDI-DI 50197106054701
- (8) Cat. PO08LXG21 - Lot #941775
Distribution
Distributed nationwide across the United States.
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