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Recall Observatory FDA recall evidence

Device product

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

Z-2622-2017

May 09, 2017

Class II

Product summary

Firm
Covidien LLC
Event
Event 77300
Status
Terminated
Classification
Class II
Quantity
194,851
Official record key
device-enforcement:Z-2622-2017

Official wording

Reason: Cotton tip of the device may disengage due to insufficient adhesive

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

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cotton tip of the device may disengage due to insufficient adhesive