Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in

FDA device recall Z-1845-2012 · posted 2012-06-21 · Terminated

Recall details

Recalling firm

Covidien LP

Reason for recall

Potential for the sterility barrier to be compromised.

Action taken

The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 16, 2012 via federal express to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately identify and quarantine all affected inventory (note: units from affected lots may have been incorporated into Covidien BEST PRACTICE KITS; evaluate kits for affected lots). All affected ROTICULATOR units must be returned. The customers were also instructed to complete and return the attached ROTICULATOR Single Use Stapler Recalled Product Return form via fax to: (800) 895-6140 or email to: SDFeedback@Covidien.com, even if you do not have any of the affected units, and include a copy of completed form with products being returned. Customers who received product directly from Covidien should contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722-8772, option 1, prior to returning affected products to Covidien, Field Returns Department, at 195 McDermott Road, North Haven, CT 06473; if received from distributor, return form and contact distributor directly. If you have any questions or concerns, please do not hesitate to contact Covidien Representative or Covidien Quality Assurance at (203) 492-5232.

Root cause

Package design/selection

Status

Terminated

Product code

GDW

Quantity affected

13531 units

Distribution

Worldwide distribution: USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPA¿A France, Ger

Date initiated

2012-05-09

Date posted

2012-06-21

Date terminated

2014-02-12

Location

North Haven, CT

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