Recall of Covidien Endo Peanut 5mm Auto Suture Blunt Dissector
Covidien LLC is recalling 194,851 units of the Endo Peanut 5mm Auto Suture Blunt Dissector because the cotton tip may disengage due to insufficient adhesive.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a component disengaging during surgery, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Covidien Endo Peanut 5mm Auto Suture Blunt Dissector, Item Code 173019. The recall covers 194,851 units distributed nationwide. The affected lots have expiration dates ranging from October 2020 through January 2022, with lot numbers from M5K04X to M7A01X.
The recall is being conducted because the cotton tip of the device may disengage due to insufficient adhesive. The instrument is indicated for use in endoscopic surgery for swabbing small amounts of fluid, for blunt dissection of soft tissues and structures, or as an aid in controlling minor intraoperative bleeding.
Healthcare facilities and distributors should stop using the affected devices and contact the recalling firm, Covidien LLC, for further instructions. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 194,851
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: M5K04X to M7A01X Exp Date: 2020-October through 2022-January
Distribution
Distributed nationwide across the United States.
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