Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnat
FDA device recall Z-0815-2012 · posted 2012-01-19 · Terminated
Recall details
- Recalling firm
- Mallinckrodt Inc
- Reason for recall
- The firm received complaints from their customers stating that they found open seals on two of their sterilized products.
- Action taken
- Mallinckrodt Inc. sent an "URGENT DEVICE RECALL" letter dated December 20, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product and to complete and return an attached Business Response form via fax to (314) 654-8206 or e-mail to imaging.recalls@covidien.com. Contact the Product Monitoring Department at 800-778-7898 for questions regarding this notice.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 63,900 units
- Distribution
- Worldwide Distribution--USA (nationwide) including the states of AZ, CA, GA, IA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, WA, WI and WV and countries of Australia, Belgium, Cana
- Date initiated
- 2011-12-20
- Date posted
- 2012-01-19
- Date terminated
- 2013-02-19
- Location
- Cincinnati, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE SYRINGE FILL TUBE (K781334) | Mallinckrodt Group, Inc. | 1978-08-17 |