Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive an
FDA device recall Z-1846-2016 · posted 2016-05-31 · Terminated
Recall details
- Recalling firm
- STERILMED, INC.
- Reason for recall
- Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
- Action taken
- Consignees were sent on /26/2016 a Sterilmed "Urgent Medical Device Recall" letter dated April 26, 2016. The letter was addressed to either Materials Manager, Risk Manager and Operating Room Director or Distributor. The letter described the problem, the product involved in the recall and the actions required. Advised consignees to immediately quarantine and return the affected product and to complete and return the "Business Reply Form" to Sterilcycle. Advised Distributors to forward the letter to their customers if product was sent to them. For questions contact Sterilmed's Customer Care Team at 1-888-541-0078 .
- Root cause
- Process design
- Status
- Terminated
- Product code
- NUJ
- Quantity affected
- 11,326
- Distribution
- US: AL, AR, CA, CO, FL, GA, IN,IA, KY, MD, MA, MI, MN, MO, NV, NJ, NC, OH, OK, OR, PA,, SC, TN, TX, VA, WA, WV, WI. Canada
- Date initiated
- 2016-04-26
- Date posted
- 2016-05-31
- Date terminated
- 2017-04-05
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REPROCESSED SCISSOR TIPS (K073613) | Sterilmed, Inc. | 2008-02-12 |