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FDA device recall Z-2821-2011 · posted 2011-07-15 · Terminated

Recall details

Recalling firm

Covidien LP

Reason for recall

Potential for the sterile barrier to be breached compromising the sterility of the product

Action taken

Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product. Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product. Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.

Root cause

Equipment maintenance

Status

Terminated

Product code

GAP

Quantity affected

3576 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore

Date initiated

2011-06-03

Date posted

2011-07-15

Date terminated

2014-02-10

Location

North Haven, CT

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