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Terminated

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 Recall Z-0456-2019 · Posted None

Recalling FirmAmerican Contract Systems, Inc.
Recall StatusTerminated
Product CodeKGO
Date Initiated2016-12-28
Date Terminated2018-11-14
Product Quantity1,180 kits

Reason for Recall

Powdered Surgical Gloves are an FDA banned substance.

Firm Action

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: [email protected].

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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