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U.S. Department of Health and Human Services

Class 2 Device Recall Lead Clipper

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  Class 2 Device Recall Lead Clipper see related information
Date Initiated by Firm July 24, 2023
Date Posted September 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-2513-2023
Recall Event ID 92791
Product Classification Instruments, surgical, cardiovascular - Product Code DWS
Product Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads.
Order Number (GPN): G20003
Reference Part Number (RPN): LR-CLP001
Code Information Device Identifier (DI): (01)00827002200036(17) Lot Numbers: N172707 N172737 N172738 N172875 N172887 N172912 N173153 N173178 N173180 N173434 N173519 N173623 N173653 N173688 N173690 N173691 N173879 N173943 N173959 N173976 N173977 N174034 N174104 N174134 N174169 N174170 N174287 N174294 N174466 N174535 N174536 N174564 N174589 N174704 N174778 N174841 N174863 N174864 N174889 N174906 N175146 N175201 N175247 N175277 N175589 N175627 N175963 N175964 N175987 N176084 N176262 N176322 N176323 N176712 N176714 N176715 N176716 N176829 N176830 N176974 N177094 N177101 N177102 N177217 N177218 N177239 N177351 N177496 N177515 N177678 N177682 N177797 N177853 N177898 N177927 N178015 N178054 N178093 N178224 N178225 N178276 N178340 N178518 N178562 N178609 N178633 N178675 N178676 N178677 N178764 N178784 N178813 N178814 N179019 N179021 N179130 N179209 N179211 N179301 N179302 N179333 N179361 N179396 N179397 N179503 N179504 N179534 N179728 N179874 N179903 N180036 N180038 N180077 N180115 N180116 N180147 N180313 N180314 N180370 N180371 N180458 N180459 N180504 N180768 N180769 N180953 N181027 N181056 N181127 N181397 N181437 N181438 N181530 N181581 N181582 N181626 N181628 N181629 N181801 N181804 N182095 N182137 N182282 N182524 N182552 N182691 N182817 N182824 N182943 N182945 N183030 N183042 N183043 N183119 N183120 N183261 N183262 N183263 N183457 N183533 N183535 N183737 N183738 N183826 N183841 N183857 N183939 N184187 N184188 N184222 N184319 N184320 N184409 N184517 N184518 N184580 N184612 N184735 N184736 N184880 N184881 N184989 N184990 N185156 N185238 N185239 N185271 N185334 N185335 N185570 N185579 N185612 N185613 N185615 N185879 N185880 N186216 N186317 N186318 N186541 N186581 N186683 N186684 N186748 N186749 N186780 N186835 N186837 N186887 N186888 N186963 N186999 N187000 N187048 N187049 N187107 N187213 N187246 N187300 N187301 N187302 N187317 N187338 N187359 N187436 N187438 N187519 N187522 N187727 N187728 N187776 N187777 N187811 N187841 N188171 N188172 N188238 N188239 N188290 N188322 N188323 N188347 N188403 N188427 N188465 N188466 N188489 N188490 N188614 N188615 N188740 N188741 N188807 N189098 N189099 N189288 N189289 N189366 N189367 N189662 N189666 N189667 N189751 N189753 N189804 N189805 N189806 N189964 N189965 N189986 N189987 N190015 N190050 N190312 N190400 N190401 N190506 N190539 N190635 N190720 N190721 N190812 N190813 N191066 N191355 N191357 N191441 N191580 N191583 N191678 N191679 N191791 N191870 N191894 N191971 N191972 N191973 N192119 N192120 N192230 N192232 N192309 N192310 N192311 N192312 N192339 N192340 N192341 N192342 N192495 N192496 N192497 N192498 N193021 N193022 N193118 N193119 N193398 N193399 N193490 N193491 N193570 N193571 N193648 N193730 N193731 N193967 N193968 N194083 N194084 N194361 N194362 N194368 N194571 N194572 N194666 N194720 N194768 N194805 N194841 N194884 N195037 N195038 N195112 N195113 N195176 N195177 N195333 N195334 N195447 N195448 N195493 N195494 N195559 N195738 N195840 N195849 NF179451
Recalling Firm/
Manufacturer		 Cook Vandergrift, Inc.
1186 Montgomery Ln
Vandergrift PA 15690-6065
For Additional Information Contact Cook Medical Customer Relations Department
800-457-4500
Manufacturer Reason
for Recall		 Sterility of device may be compromised due to breach of the chevron seal of the packaging
FDA Determined
Cause 2		 Under Investigation by firm
Action Cook Medical Vandergrift issued URGENT: Medical Device Recall letter on July 24, 2023. Letter states reason for recall, health risk and action to take: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical Vandergrift with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. We look forward to your return of the Acknowledgement and Receipt Form.
Quantity in Commerce 15,951
Distribution Worldwide distribution - US Nationwide including PR and the countries of AE, AT, AU, BE, BN, BY, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GT, HK, HU, IE, IL (EUDC), IL (NADC), IT, JP, KW, MX, NL, NO, PL, PR, PT, SE, TH, TR, UY, ZA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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