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Terminated

BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131

FDA Recall Z-0609-2018 · Posted 2018-02-01

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLYU
Date Initiated2017-09-11
Date Terminated2018-08-30
Product Quantity1863

Reason for Recall

Cut resistant surgical glove liners lack sterility assurance.

Firm Action

1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1 Certificate of Acknowledgement. a. Return a digital copy to [email protected]. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to [email protected].

Root Cause

Process control

Distribution Pattern

Distributed in 29 states: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WV and Washington, DC. Distributed to 1 Veteran's Administration hospital in MO. Distributed in Netherland, Peru, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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