Tri-Staple 2.0 surgical stapler cartridge damage may cause incomplete stapling
Covidien is recalling 1681 units of Tri-Staple 2.0 surgical staples due to potential cartridge damage that may result in poor staple formation and incomplete staple lines during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall of a surgical device where potential cartridge damage could result in poor staple formation and incomplete staple lines during surgery. No illnesses or injuries have been reported. The score of 3 (High) reflects that this is a risk-of-harm surgical device where injury has not yet been reported, per the severity rubric.
Plain-English summary
Covidien, LP is recalling 1681 units of Tri-Staple 2.0 Black Reinforced Intelligent Reload surgical staples (Model SIGTRSB60AXT). These devices are used in abdominal, gynecologic, pediatric, and thoracic surgery for tissue resection, transection, and anastomosis creation.
The recalled units may have damage to the cartridge that can result in poor staple formation and incomplete staple lines during surgery. This defect may cause delays in surgical procedures.
The affected devices were distributed worldwide, including nationwide in the United States (specifically in New Jersey) and internationally to Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand. The recalled lot number is N3G1372Y.
Healthcare facilities and providers who may have received these units should verify their inventory and contact Covidien regarding this recall.
The recalled product
- Product
- Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
- Manufacturer
- Covidien, LP
- Affected units
- 1,681
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)
- GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
Distribution
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