Presource Laparoscopy Kit Recalled for Lack of Sterility Assurance
Cardinal Health is recalling Presource Kit laparoscopy surgical packs due to being released without sterility assurance. Affected units may harbor contamination and pose a risk during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall of a surgical device released without sterility assurance. While the product poses a risk of contamination in surgical settings, no illnesses, injuries, or hospitalizations have been reported. This meets the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling the Presource Kit, Model SMA21LPUHJ GYN Laparoscopy Pack, a surgical convenience kit used in laparoscopic gynecological procedures. Five units of Lot Number 019693 were distributed to healthcare facilities in Georgia.
The kits were inadvertently released for distribution without sterility assurance. The surgical instruments and components in the kits have not been confirmed to meet required sterility standards, which is essential for patient safety during surgical procedures.
Affected healthcare facilities and consumers who have obtained these kits should contact Cardinal Health 200, LLC for further guidance on the recall.
The recalled product
- Product
- Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 5
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 (2)
- Catalog Number: SMA21LPUHJ
- Lot Number: 019693
Distribution
Distributed in 1 state:
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