Recall Z-2497-2019 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Aesculap Implant Systems LLC
CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
| Date | Aug 7, 2019 |
| Status | Terminated |
| Reason | possibility of the sterility batch being insufficiently sterilized |
| Root cause | Unknown/Undetermined by firm |
| Action | 1. Immediately examine your inventory and quarantine product. 2. Determine your current inventory of the affected product within your facility. Do not destroy any affected product. 3. Fill out and return the completed "the Medical Device Recall Acknowledgement Response Form " along with the product to the to the address : Aesculap Inc. Attn: Ted Dachroeden 615 Lambert Pointe Drive Hazelwood, MO 63042 4. Please Contact Customer Service for an RGR number and call tag to return your affected product. You will receive credit for your returned product. AIC Customer Service Number 1-800-282-900 |
| Quantity | 0 |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093075 | ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT Aragon Surgical, Inc., Jan 21, 2010 |