| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | February 11, 2025 |
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| Date Posted | March 25, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1447-2025 |
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| Recall Event ID |
96374 |
| Product Classification |
Gynecological laparoscopic kit - Product Code OHD
|
| Product | Medline procedure kits labeled as:
1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D;
2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I;
3) DAVINCI PACK-RFD, Pack Number DYNJ47762O;
4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236;
5) GENERAL ROBOTICS PACK, Pack Number DYNJ80546B;
6) GYN 1 PACK, Pack Number DYNJ43441C;
7) GYN LAP, Pack Number DYNJ909936;
8) GYN LAPAROSCOPY PACK, Pack Number DYNJ63014A;
9) GYN LAPAROSCOPY PACK, Pack Number DYNJ51739B;
10) GYN LAPAROSCOPY PACK, Pack Number DYNJ84181;
11) GYN LAPAROSCOPY PACK, Pack Number SYNJ10073D;
12) GYN LAPAROSCOPY PACK-LF, Pack Number DYNJ0124452S;
13) LAP GYN PACK-LF, Pack Number PHS988229I;
14) LAPAROSCOPIC GYN PACK, Pack Number DYNJ47274J;
15) MOR GYN, Pack Number DYNJ902845K;
16) PELVISCOPY PACK-LF, Pack Number DYNJ0843760F;
17) ROBOTIC GYN, Pack Number DYNJ909233;
18) ROBOTIC RENAL PACK, Pack Number DYNJ50238C;
19) SCRIPPS SW ROBOTIC PACK, Pack Number DYNJ52564D;
20) SVMMC GYN ROBOTIC PACK, Pack Number DYNJ43782K;
21) TASC GYN LAP, Pack Number DYNJ49191B;
22) URO-GYN ROBOTIC PACK, Pack Number DYNJ37717K |
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| Code Information |
1) Pack Number DYNJ61061D: UDI/DI 10195327451509 (each) 40195327451500 (case), Lot Number 23GMD257A;
2) Pack Number DYNJ0665103I: UDI/DI 10193489395211 (each) 40193489395212 (case), Lot Number 23ABM287A;
3) Pack Number DYNJ47762O: UDI/DI 10195327478742 (each) 40195327478743 (case), Lot Number 23IMF676A;
4) Pack Number DYNJ81236: UDI/DI 10195327096618 (each) 40195327096619 (case), Lot Number 23LMH303A;
5) Pack Number DYNJ80546B: UDI/DI 10195327211097 (each) 40195327211098 (case), Lot Number 23FBP444A;
6) Pack Number DYNJ43441C: UDI/DI 10193489323177 (each) 40193489323178 (case), Lot Number 21LBG879A;
7) Pack Number DYNJ909936: UDI/DI 10195327511203 (each) 40195327511204 (case), Lot Number 23JBI037Z;
8) Pack Number DYNJ63014A: UDI/DI 10193489245684 (each) 40193489245685 (case), Lot Number 20BDB396A;
9) Pack Number DYNJ51739B: UDI/DI 10889942975884 (each) 40889942975885 (case), Lot Number 22ABT041A;
10) Pack Number DYNJ84181: UDI/DI 10195327340360 (each) 40195327340361 (case), Lot Number 23KMC229A;
11) Pack Number SYNJ10073D: UDI/DI 10193489864540 (each) 40193489864541 (case), Lot Number 24ABA922Z;
12) Pack Number DYNJ0124452S: UDI/DI 10193489754216 (each) 40193489754217 (case), Lot Number 20HKB312A;
13) Pack Number PHS988229I: UDI/DI 10193489766035 (each) 40193489766036 (case), Lot Number 23GMB353A;
14) Pack Number DYNJ47274J: UDI/DI 10193489353631 (each) 40193489353632 (case), Lot Number 21IMG979A;
15) Pack Number DYNJ902845K: UDI/DI 10195327210199 (each) 40195327210190 (case), Lot Number 24AMD941Z;
16) Pack Number DYNJ0843760F: UDI/DI 10193489607833 (each) 40193489607834 (case), Lot Number 20BDB045A;
17) Pack Number DYNJ909233: UDI/DI 10195327310189 (each) 40195327310180 (case), Lot Number 23GBA187Z;
18) Pack Number DYNJ50238C: UDI/DI 10195327017484 (each) 40195327017485 (case), Lot Number 23HMC447A;
19) Pack Number DYNJ52564D: UDI/DI 10195327176426 (each) 40195327176427 (case), Lot Number 23GME685A;
20) Pack Number DYNJ43782K: UDI/DI 10193489989892 (each) 40193489989893 (case), Lot Number 22HBO266M;
21) Pack Number DYNJ49191B: UDI/DI 10193489497489 (each) 40193489497480 (case), Lot Number 21JMH124A;
22) Pack Number DYNJ37717K: UDI/DI 10195327409753 (each) 40195327409754 (case), Lot Number 23GME305A |
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers.
This is an expansion of RES 94583 |
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| Quantity in Commerce | 1711 units |
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| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
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| Total Product Life Cycle | TPLC Device Report |
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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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