—#166267

Product

Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients.

FDA product code: KGO — Surgeon'S Gloves
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Tray Number (Powdered Glove code): MHCE23D (ANS5711104), MHAP41D (ANS7825), MHOC43C (ANS7825), MHPO42D (ANS7825), GVTH071 (ANS5711104), GVTK05L (ANS5711104), GVTK05M (ANS5711104), CXTR68D (ANS5711105), MDEY35H (BAX2D7202I), MDEY35I (BAX2D7202I), FHLV24 (ANS5711105, ANS5711101), LKCA02A (ANS5710503), WIDE32 (ANS7824), UTLU70F (ANS7825), FIOH02H (BAX2D7254)

Why it was recalled

Powdered Surgical Gloves are an FDA banned substance.

Root cause (FDA determination)

Other

Action the firm took

The firm, ACS, notified Customers via phone call and email on about 12/28/2016. The customers were informed about the product, problem and actions to be taken. The customers were instructed to identify and remove all the affected kits for replacement of the recalled gloves; tray insert label must reflect the omission of the powered gloves; and ban, quarantine and return affected product. If you have any questions, contact that Quality Manager at 816-920-5846 or email to: tbakke@amconsys.com.

Recalling firm

Firm: American Contract Systems, Inc.
Address: 2610 Ne Industrial Dr, Ste 220, Kansas City, Missouri 64117-2648

Distribution

Distribution pattern: US Distribution to states of: IL, MO, NE, and OH.

Timeline

Recall initiated: 2016-12-28
Terminated: 2018-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166267. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.