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.
Recall
- Recall Number
- Z-2497-2019
- Event Number
- 83637
- Firm
- Aesculap Implant Systems LLC
- FEI Number
- 2916714
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- August 7, 2019
- Terminated
- May 12, 2020
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217
Description
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.
possibility of the sterility batch being insufficiently sterilized
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 [email protected] 5. If the total inventory in your possession is zero (0), please return the form to: [email protected] Fax: 610-791-6882 If you have any questions, please contact, Josie McBride at (610) 984-9290.
US Nationwide distribution in the state of CA.
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