Cardinal Health Recalls Presource Procedure Packs Due to Sterility Concerns
Cardinal Health is recalling Presource Procedure Packs containing AAMI Level 3 surgical gowns because they may not be sterile. This could increase the risk of surgical site infections.
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: The recall involves a risk-of-harm product (non-sterile surgical gowns) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Cardinal Health 200, LLC is recalling Presource Procedure Packs that contain AAMI Level 3 surgical gowns. The affected units were produced between September 1, 2018, and January 15, 2020, and are identified by specific catalog numbers and lot codes listed in the recall notice. Approximately 318,000 units were distributed nationwide in the US, as well as in Chile, Israel, and the UAE.
The recall was initiated because 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. The use of inadequately sterilized surgical gowns could compromise a sterile field during a procedure, thereby increasing the risk of a surgical site infection.
Healthcare facilities and consumers should stop using the affected Presource Procedure Packs immediately. Users should check their inventory against the list of catalog numbers and lot codes provided in the official recall notice to identify affected units. For more information, contact Cardinal Health 200, LLC or refer to the FDA recall notice Z-1301-2020.
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
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Gowns
- Affected units
- 318,000
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: PB08GAGHS 521235
- PB08GAGHS 529320
- PB08GAGHS 554815
- PB08GAGHS 557236
- PB08GAGHS 560162
- PB08GAGHS 562676
- PB08GIGHR 552864
- PB08GIGHR 559707
- PB08GIGHR 561420
- PB08HSGH5 517846
- PB08HSGHK 504968
- PB08HSGHK 544674
- PB08HSGHK 554810
- PB08HSGHK 558443
- PB08HSGHK 562679
- PB08IVGH3 519354
- PB08IVGHO 503340
- PB08IVGHO 509979
- PB08IVGHO 551950
- PB08IVGHO 554195
Distribution
Distributed nationwide across the United States.
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