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.
- Company
- Aesculap Implant Systems Llc
- Recall Initiated
- August 7, 2019
- Terminated
- May 12, 2020
- Recall Number
- Z-2496-2019
- Quantity
- 3 unit of Lot 837B
- Firm Location
- Center Valley, PA
Reason for Recall
possibility of the sterility batch being insufficiently sterilized
Distribution
US Nationwide distribution in the state of CA.
Lot / Code Info
Lot # 109C and 837B
Root 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.