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Terminated

Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.

FDA Recall Z-0162-2018 · Posted 2017-11-21

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeKGO
Date Initiated2017-10-23
Date Terminated2021-04-06
Product Quantity8,000 units

Reason for Recall

Possible open seal on top portion of the package. Could cause breach of sterility.

Firm Action

Medline Industries sent an Immediate Action Required Letter dated October 23, 2017, to all affected customers.. Instructions included to check inventory and quarantine affected product, complete and return the response form to Medline, arrange for the return of any affected product, and notify any customers if the product was further distributed. Customers with questions were instructed to call 866-359-1704.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040503ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOURWrp Asia Pacific Sdn. Bhd. · 2004-03-16

Official Source

View FDA Recall →

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

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