Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DU
FDA device recall Z-1227-2012 · posted 2012-03-19 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- Missing component results in the stapler not firing.
- Action taken
- The firm, Covidien, sent a "Medical Device Recall" letter dated February 16, 2012 to customers via federal express. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of Lot# N1H003LX of Duet TRS Articulating Loading Unit and segregate affected product; return inventory to Field Returns Department, 195 McDermott Road, North Haven, CT 06473 and contact customer service at SDFeedback@Covidien.com or (800) 722-8772, option #1 for RGA # prior to returning; and complete and return the Recall Product Return Form via fax to (203) 822-6009 (all affected units must be returned with completed form through the Distributor). If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance at 203-492-5232, or Customer Service at 800-722-877 option 1 customer service.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 1158 units
- Distribution
- Worldwide distribution: USA (nationwide) and country of: Venezuela.
- Date initiated
- 2012-02-16
- Date posted
- 2012-03-19
- Date terminated
- 2021-03-04
- Location
- North Haven, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT (K080898) | Tyco Healthcare Group LP | 2008-05-05 |