Device product

FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006

Z-1628-2022

May 25, 2022

Class II

Product summary

Firm: Mckesson Medical-Surgical Inc. Corporate Office
Event: Event 90336
Status: Ongoing
Classification: Class II
Quantity: 7 packs
Official record key: device-enforcement:Z-1628-2022

Official wording

Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Code information: Not available

Distribution pattern: US Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.