| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | September 04, 2024 |
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| Date Posted | October 23, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0161-2025 |
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| Recall Event ID |
95415 |
| Product Classification |
laparoscopy kit - Product Code FDE
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| Product | Medline brand medical procedure convenience kits, labeled as:
1) CYSTO CDS, REF CDS983525D;
2) CYSTO CDS, REF CDS983525D;
3) CYSTO PACK-LF, REF DYNJ25834B;
4) CYSTO PACK, REF DYNJ35569C;
5) PAVILION MINOR PACK, REF DYNJ40724D;
6) CYSTOSCOPY PACK, REF DYNJ41105C;
7) MINOR PACK, REF DYNJ42132A;
8) RECTAL PRONE PACK, REF DYNJ43380A;
9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716;
10) CYSTO PACK, REF DYNJ47821F;
11) CYSTO PACK, REF DYNJ48978C;
12) CYSTO PACK, REF DYNJ50428C;
13) MID HUDSON CYSTO PACK, REF DYNJ53418B;
14) CYSTO PACK-LF, REF DYNJ55479D;
15) CYSTO PACK, REF DYNJ58445A;
16) MINOR PACK, REF DYNJ58566B;
17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431;
18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A;
19) FLEXIBLE CYS PACK, REF DYNJ62111C;
20) CYSTO PACK, REF DYNJ65830A;
21) MAIN & ODS CYSTO PACK, REF DYNJ66821A;
22) PROCEDURE CYSTO PACK, REF DYNJ68883;
23) CYSTO PACK, REF DYNJ69729;
24) MINOR SURGERY PACK, REF DYNJ80004;
25) LAPAROSCOPY PACK, REF DYNJ80763;
26) LAPAROSCOPY PACK, REF DYNJ80763;
27) CYSTO PACK, REF DYNJ82626;
28) MINOR PACK, REF DYNJ83155;
29) SY CYSTO, REF DYNJ900583M;
30) CYSTO, REF DYNJ905569B;
31) CYSTO, REF DYNJ907541A;
32) SET UP PACK-LF, REF LLSCASET01;
33) MAJOR PACK, REF SYNJ910011B |
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| Code Information |
1) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 24ABW238;
2) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 23KBU714;
3) REF DYNJ25834B, UDI/DI 40193489849555 (each) 10193489849554 (case), Lot Numbers: 24ABG332;
4) REF DYNJ35569C, UDI/DI 40195327498253 (each) 10195327498252 (case), Lot Numbers: 23LBL736;
5) REF DYNJ40724D, UDI/DI 40195327420773 (each) 10195327420772 (case), Lot Numbers: 24ABG713;
6) REF DYNJ41105C, UDI/DI 40193489969659 (each) 10193489969658 (case), Lot Numbers: 24ABA628;
7) REF DYNJ42132A, UDI/DI 40195327385270 (each) 10195327385279 (case), Lot Numbers: 23LBS108;
8) REF DYNJ43380A, UDI/DI 40888277265913 (each) 10888277265912 (case), Lot Numbers: 23KBD028;
9) REF DYNJ46716, UDI/DI 40888277597069 (each) 10888277597068 (case), Lot Numbers: 23LBM976;
10) REF DYNJ47821F, UDI/DI 40193489956796 (each) 10193489956795 (case), Lot Numbers: 24ABC507;
11) REF DYNJ48978C, UDI/DI 40195327325948 (each) 10195327325947 (case), Lot Numbers: 23LBP883;
12) REF DYNJ50428C, UDI/DI 40195327504039 (each) 10195327504038 (case), Lot Numbers: 23LBN301;
13) REF DYNJ53418B, UDI/DI 40195327372270 (each) 10195327372279 (case), Lot Numbers: 23LBO773;
14) REF DYNJ55479D, UDI/DI 40195327416769 (each) 10195327416768 (case), Lot Numbers: 23LBL444;
15) REF DYNJ58445A, UDI/DI 40195327585953 (each) 10195327585952 (case), Lot Numbers: 23LBU911;
16) REF DYNJ58566B, UDI/DI 40195327243228 (each) 10195327243227 (case), Lot Numbers: 23KBC919;
17) REF DYNJ59431, UDI/DI 40888277741257 (each) 10888277741256 (case), Lot Numbers: 24ABG210;
18) REF DYNJ60077A, UDI/DI 40193489862905 (each) 10193489862904 (case), Lot Numbers: 23LBO542;
19) REF DYNJ62111C, UDI/DI 40195327312146 (each) 10195327312145 (case), Lot Numbers: 23LBP204;
20) REF DYNJ65830A, UDI/DI 40195327588732 (each) 10195327588731 (case), Lot Numbers: 23LBR366;
21) REF DYNJ66821A, UDI/DI 40193489974929 (each) 10193489974928 (case), Lot Numbers: 23KBQ852;
22) REF DYNJ68883, UDI/DI 40193489848329 (each) 10193489848328 (case), Lot Numbers: 23KBC527;
23) REF DYNJ69729, UDI/DI 40193489973267 (each) 10193489973266 (case), Lot Numbers: 24ABD664;
24) REF DYNJ80004, UDI/DI 40195327005192 (each) 10195327005191 (case), Lot Numbers: 23LBP094;
25) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 24ABG464;
26) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 23LBU050;
27) REF DYNJ82626, UDI/DI 40195327199488 (each) 10195327199487 (case), Lot Numbers: 24ABN216;
28) REF DYNJ83155, UDI/DI 40195327236855 (each) 10195327236854 (case), Lot Numbers: 23LBV474;
29) REF DYNJ900583M, UDI/DI 40195327061853 (each) 10195327061852 (case), Lot Numbers: 24ABU214;
30) REF DYNJ905569B, UDI/DI 40193489995672 (each) 10193489995671 (case), Lot Numbers: 24ABJ966;
31) REF DYNJ907541A, UDI/DI 40195327054268 (each) 10195327054267 (case), Lot Numbers: 23KBT202;
32) REF LLSCASET01, UDI/DI 40080196120681 (each) 10080196120680 (case), Lot Numbers: 23LBM079;
33) REF SYNJ910011B, UDI/DI 40195327246809 (each) 10195327246808 (case), Lot Numbers: 24ABS212
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Karin Johnson
866-359-1704 |
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Manufacturer Reason
for Recall | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees. |
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| Quantity in Commerce | 5972 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
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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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