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MediChoice

OWENS & MINOR DISTRIBUTION, INC. · Model CLC1033B · UDI-DI 10885632058585

PEZ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Tray Dressing Change 1 EA Dres: Tegaderm 4X4.75 1 EA Tape: Transparent Strip 1X4 1 EA Anti: Chloraprep 3ml w/Insert 1 EA Anti: Skin Protectant Swab 1 1 EA Towel: 13X18 2ply Folded 1 PR Glove: Nitrile Med Pf Purp Wal 1 EA Label: Drug Addition Pink 1 EA Bag: Zip 9x12 2ml Clr 2 EA Mask: W/Earloop Folded 2 EA Cap: Bouffant Blu 24in

Recalls

Date	Firm	Reason
2021-09-08	Medical Action Industries, Inc. 306	The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
2021-04-09	Medical Action Industries, Inc. 306	Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
2021-04-09	Medical Action Industries, Inc. 306	Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
2020-05-04	Resource Optimization & Innovation LLC	There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.