Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1742-2017Class II

Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride...

Medtronic, Inc. / initiated 2017-03-03 / Terminated / root cause: packaging

Covidien LLC began a recall of Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline... on . FDA classified it as Class II and gives the reason as "Product sterility is compromised due to breach of sterile barrier". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1742-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic, Inc.
Product
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Product code
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Reason for recall
Product sterility is compromised due to breach of sterile barrier
Root cause tag
packaging
FDA root cause
Packaging process control
Action
Medtronic/Covidien) initiated recall by letter on March 3, 2017 via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Contact Medtronic representative or Customer Service at (800) 882-5878 For questions regarding this recall call 203-492-5000.
Quantity in commerce
104688
Distribution
Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, and United Kingdom.
Product codes and lots
Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1742-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1739-2017Class IITerminatedVoluntary: Firm initiated
Z-1740-2017Class IITerminatedVoluntary: Firm initiated
Z-1741-2017Class IITerminatedVoluntary: Firm initiated
Z-1742-2017Class IITerminatedVoluntary: Firm initiated
Z-1743-2017Class IITerminatedVoluntary: Firm initiated
Z-1744-2017Class IITerminatedVoluntary: Firm initiated
Z-1745-2017Class IITerminatedVoluntary: Firm initiated