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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1739-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1740-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1741-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1742-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1743-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1744-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1745-2017 | Class II | Terminated | Voluntary: Firm initiated |
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