Cardinal Health Recalls Presource Procedure Packs with Potential Sterility Issues
Cardinal Health is recalling Presource Procedure Packs containing AAMI Level 3 surgical gowns because they may not be sterile due to improper environmental conditions during manufacturing.
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: The recall is classified as FDA Class II, and the hazard involves a risk of surgical site infection due to potential lack of sterility, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Presource Procedure Packs that contain AAMI Level 3 surgical gowns. The recall involves multiple catalog numbers produced between September 1, 2018, and January 15, 2020, with additional kits produced through February 19, 2020. The total quantity affected is 2,161,526 units, plus 113,711 additional units as of February 25, 2020.
The gowns were manufactured at locations that did not maintain proper environmental conditions. As a result, there is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
The affected products were distributed nationwide in the United States. Healthcare facilities and consumers should check their inventory for the specific catalog numbers and lot codes listed in the official recall notice. If the products are found, they should be removed from use and returned to the supplier or Cardinal Health for credit or replacement.
The recalled product
- Product
- Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Gowns
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)
- Catalog Number and Lot Code: CHIP99CP6C 241107
- CHIP99CP6C 255309
- CHIP99CP6C 299932
- CHIP99CP8A 181346
- CHIP99CP8A 282695
- CHIP99CP8A 282696
- CHIP99CP8A 282697
- CHIP99HA1B 165018
- CHIP99HA1B 248383
- CHIP99HA1B 305740
- CHIP99HA1B 330666
- CHIP99HA1B 363766
- CHIP99LC1F 118473
- CHIP99LC1F 279185
- CHIP99LC1F 298252
- CHIP99LC1F 309240
- CHIP99LC1F 340201
- CHIP99LC1F 340315
- CHIP99LC1F 367435
- CHIP99LC2E 248115
Distribution
Distributed nationwide across the United States.
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