Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile in
FDA device recall Z-1943-2012 · posted 2012-07-05 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- Reason for recall
- Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
- Action taken
- Integra sent an Urgent - Medical Device Recall letter dated June 7, 2012, to one domestic consignee via Federal Express with a recall acknowledgement form followed up with a telephone call. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the Recall Acknowledgement Form including quantity of affected product in their inventory. Customers were also instructed to contact Integra Pain Management Customer Service to arrange for returns of all affected product. Product reconciliation will be performed to account for all affected products returned. Returned product will be reprocessed to correct for the missing components. Customers with questions were instructed to call Integra Pain Management Customer Service at 1-800-241-2210. For questions regarding this recall call 609-936-2311.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 4 cases x 10 units per case
- Distribution
- Nationwide Distribution including MA
- Date initiated
- 2012-06-07
- Date posted
- 2012-07-05
- Date terminated
- 2012-08-07
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PIDURAL STEROID SYSTEM (K945484) | Professional Medical Device Consultants | 1995-06-02 |