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Recall Observatory FDA recall evidence

Device product

McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121

Z-2473-2021

August 11, 2021

Class II

Product summary

Firm
Cypress Medical Products LLC
Event
Event 88561
Status
Terminated
Classification
Class II
Quantity
1 case (40 packs/cs)
Official record key
device-enforcement:Z-2473-2021

Official wording

Reason: Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators did not change

Code information: Lot number: CJJ12-07

Distribution pattern: VA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators did not change