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Terminated

SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147

FDA Recall Z-0896-2017 · Posted None

Recalling FirmRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Recall StatusTerminated
Product CodeFSM
Date Initiated2016-11-15
Date Terminated2018-06-21
Product QuantityUS: 82 cases

Reason for Recall

Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

Firm Action

Busse Hospital Disposables sent a Medical Device Correction letter (dated November 11, 2016) and response form to the three customers via FedEx on 11/15/2016 to inform them of the recall of the kits containing the affected gloves. This was done without notifying NYK-DO.

Root Cause

Other

Distribution Pattern

PA, FL, VA

Official Source

View FDA Recall →

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

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