Z-2622-2017 Class II Terminated

Recalled by Covidien LLC — North Haven, CT

FDA device recall Z-2622-2017 was initiated by Covidien LLC on May 9, 2017 and is designated Class II. Reason for recall: Cotton tip of the device may disengage due to insufficient adhesive The recall status is terminated (terminated February 13, 2019). Affected quantity: 194,851.

Recall Details

Product Type
Devices
Report Date
July 5, 2017
Initiation Date
May 9, 2017
Termination Date
February 13, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
194,851

Product Description

Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding

Reason for Recall

Cotton tip of the device may disengage due to insufficient adhesive

Distribution Pattern

Nationwide Distribution

Code Information

Lot Numbers: M5K04X to M7A01X Exp Date: 2020-October through 2022-January