GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with th
FDA device recall Z-1175-06 · posted 2006-06-27 · Terminated
Recall details
- Recalling firm
- Gyrus Medical, Inc.
- Reason for recall
- Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indicated that the possibility exists.
- Action taken
- US accounts were initially contacted by phone beginning 05/15/2006 and then sent a follow-up letter sent 05/31/2006. Customers were told of the issue, instructed to discontinue use of the product, told to remove all 2103PK and 917015PK devices from shelves and to quarantine product until they receive a letter with instructions to return the affected devices to Gyrus ACMI.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 2971 (2931 domestic, 40 OUS)
- Distribution
- Nationwide, Australia, Canada, Netherlands. (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA,
- Date initiated
- 2006-05-15
- Date posted
- 2006-06-27
- Date terminated
- 2007-01-12
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT (K020585) | Gyrus Medical, Inc. | 2002-07-13 |