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U.S. Department of Health and Human Services

Class 2 Device Recall CAIMAN DISP.INSTR.ARTICULAT.D

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  Class 2 Device Recall CAIMAN DISP.INSTR.ARTICULAT.D see related information
Date Initiated by Firm August 07, 2019
Create Date September 09, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-2496-2019
Recall Event ID 83637
510(K)Number K093075  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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.
Code Information Lot # 109C and 837B
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Josephine McBride
610-984-9290
Manufacturer Reason
for Recall		 possibility of the sterility batch being insufficiently sterilized
FDA Determined
Cause 2		 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 1-800-282-9000 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.
Quantity in Commerce 3 unit of Lot 837B
Distribution US Nationwide distribution in the state of CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = ARAGON SURGICAL INC.
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