Agency classClass IIOur severity:High FDA (Devices)·Z-1301-2020·Announced 2020-02-26

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.

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 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
Hazard: infection
sterility-failure
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.

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · infection