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Recall Observatory FDA recall evidence

Device product

Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

Z-0711-2024

November 29, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93560
Status
Ongoing
Classification
Class II
Quantity
2,100 gowns
Official record key
device-enforcement:Z-0711-2024

Official wording

Reason: Surgical gowns were manufactured with the wrong sleeve.

Code information: Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.

Distribution pattern: Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Surgical gowns were manufactured with the wrong sleeve.