Recalls / —

—#194872

Product

Various ob/gyn packs

FDA product code

MLS — Labor And Delivery Kit

Device class

Class 2

Medical specialty

Obstetrics/Gynecology

Affected lot / code info

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSROBDELIVC, 2104091, 904211, 14531604 2) LSRVAGDELIVC, 2106011, 863211, 44252284 3) LSRVAGDELIVC, 2106011, 863211, 44135283 4) LSRCFHVAGDC, 2108042, 791211, 64123598 5) LSRCFHVAGDC, 2108042, 791211, 64123599 6) LSRCFHVAGDC, 2108042, 791211, 64123597 7) LSRVAGDELIVC, 2108181, 776211, 44139780 8) LSROBDELIVC, 2109231, 743211, 64319309 9) UPVD01G, 2109211, 741211, 15187693 10) MEVG08P, 2105132, 873211, 14874335-004 11) SLOB77F, 2108101, 779211, 15093748-004 12) MEVG08Q, 2108192, 770211, 15103947-004 13) BHVG89C, 2104291, 887211, 14962314-004 14) BHVG89C, 2106303, 827211, 14956518-004 15) AGOB35D, 2107221, 799211, 64183198-006

Why it was recalled

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Root cause (FDA determination)

Process change control

Action the firm took

The recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022. Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm. A Field Action Response Form should be completed and returned to angela.bunn@owens-minor.com as soon as possible, even if the customer has no inventory. If you have any questions, please call 816-920-5846.

Recalling firm

Firm

American Contract Systems, Inc.

Address

2610 Ne Industrial Dr, Ste 220, Kansas City, Missouri 64117-2648

Distribution

Distribution pattern

Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Timeline

Recall initiated

2022-06-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #194872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.