Recall Z-2496-2019
Aesculap Implant Systems LLC · initiated August 7, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
Codes / lots: Lot # 109C and 837B
Reason for recall
possibility of the sterility batch being insufficiently sterilized
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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 1-800-282-9000 Aesculap_Emailorders.BBmus_service@aesculapusa.com 5. If the total inventory in your possession is zero (0), please return the form to: Josie.mcbride@aesculapusa.com Fax: 610-791-6882 If you have any questions, please contact, Josie McBride at (610) 984-9290.
Details
- Recall number
- Z-2496-2019
- Initiated
- August 7, 2019
- Terminated
- May 12, 2020
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 3 unit of Lot 837B
- Distribution
- US Nationwide distribution in the state of CA.
- Recalling firm
- Aesculap Implant Systems LLC, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2497-2019 Class II | CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended…possibility of the sterility batch being insufficiently sterilized | 08/07/2019Terminated |