| | 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-0160-2025 |
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| Recall Event ID |
95415 |
| Product Classification |
Ear, nose, and throat surgical tray - Product Code OGR
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| Product | Medline brand medical procedure convenience kits, labeled as:
1) T&A CDS-LF, REF CDS982091I;
2) TONSIL CDS, REF CDS984492B;
3) RV T&A PACK-LF, REF DYNJ0798129I;
4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I;
5) APU LINE PACK, REF DYNJ37171A;
6) T&A PACK-LF, REF DYNJ40836F;
7) ENT PACK, REF DYNJ44249J;
8) TONSIL PACK, REF DYNJ44349L;
9) TONSIL PACK, REF DYNJ44349M;
10) NASAL PACK, REF DYNJ53200C;
11) TONSIL & ADENOIDS PACK, REF DYNJ53270C;
12) FTMC MYRINGOTOMY PACK-LF, REF DYNJ54610A;
13) HEAD AND NECK PACK, REF DYNJ55255C;
14) ENT T&A PACK, REF DYNJ58979;
15) EENT PACK, REF DYNJ62927;
16) ENT, REF DYNJ63190A;
17) D L B PACK, REF DYNJ66274A;
18) ASC T&A, REF DYNJ67109B;
19) TONSIL T AND A PACK SHD, REF DYNJ68417C;
20) T A PACK, REF DYNJ80227B;
21) TONSIL AND ADENOID PACK, REF DYNJ80559A;
22) T AND A PACK UMMC KIT, REF DYNJ81880;
23) T/A ENDO PACK, REF DYNJ83158;
24) JVL - MODULE T A PK, REF DYNJ84083;
25) T&A, REF DYNJ900289J;
26) T&A, REF DYNJ900289J;
27) T & A, REF DYNJ902626G;
28) LARYNGOSCOPY BRONCH-LF, REF DYNJ903264A;
29) T&A, REF DYNJ903428J;
30) T&A, REF DYNJ903428J;
31) PEDI ENT - OAKBEND, REF DYNJ905769;
32) T & A, REF DYNJ907056C;
33) ASC FARRELL T&A, REF DYNJ908132;
34) CHS ENT PACK, REF DYNJCH500 |
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| Code Information |
1) REF CDS982091I, UDI/DI 40193489741644 (each), 10193489741643 (case), Lot Numbers: 24BBA623;
2) REF CDS984492B, UDI/DI 40193489637183 (each), 10193489637182 (case), Lot Numbers: 24ABB114;
3) REF DYNJ0798129I, UDI/DI 40195327226511 (each), 10195327226510 (case), Lot Numbers: 23KBB859;
4) REF DYNJ30591I, UDI/DI 40193489962841 (each), 10193489962840 (case), Lot Numbers: 24ABD228;
5) REF DYNJ37171A, UDI/DI 40884389750620 (each), 10884389750629 (case), Lot Numbers: 23KBD998;
6) REF DYNJ40836F, UDI/DI 40195327059539 (each), 10195327059538 (case), Lot Numbers: 23LBQ627;
7) REF DYNJ44249J, UDI/DI 40195327483020 (each), 10195327483029 (case), Lot Numbers: 23KBE536;
8) REF DYNJ44349L, UDI/DI 40195327394531 (each), 10195327394530 (case), Lot Numbers: 23KBD353;
9) REF DYNJ44349M, UDI/DI 40195327564378 (each), 10195327564377 (case), Lot Numbers: 24ABA446;
10) REF DYNJ53200C, UDI/DI 40193489779371 (each), 10193489779370 (case), Lot Numbers: 23KBC298;
11) REF DYNJ53270C, UDI/DI 40193489812566 (each), 10193489812565 (case), Lot Numbers: 23KBA462;
12) REF DYNJ54610A, UDI/DI 40195327456451 (each), 10195327456450 (case), Lot Numbers: 24ABD026;
13) REF DYNJ55255C, UDI/DI 40195327493753 (each), 10195327493752 (case), Lot Numbers: 23KBD956;
14) REF DYNJ58979, UDI/DI 40889942914938 (each), 10889942914937 (case), Lot Numbers: 24ABD861;
15) REF DYNJ62927, UDI/DI 40193489700245 (each), 10193489700244 (case), Lot Numbers: 23LBQ806;
16) REF DYNJ63190A, UDI/DI 40193489304603 (each), 10193489304602 (case), Lot Numbers: 23LBN122;
17) REF DYNJ66274A, UDI/DI 40195327151981 (each), 10195327151980 (case), Lot Numbers: 24ABB272;
18) REF DYNJ67109B, UDI/DI 40195327207084 (each), 10195327207083 (case), Lot Numbers: 24ABC426;
19) REF DYNJ68417C, UDI/DI 40195327341634 (each), 10195327341633 (case), Lot Numbers: 23KBC605;
20) REF DYNJ80227B, UDI/DI 40195327220144 (each), 10195327220143 (case), Lot Numbers: 24ABC423;
21) REF DYNJ80559A, UDI/DI 40195327512522 (each), 10195327512521 (case), Lot Numbers: 23LBP334;
22) REF DYNJ81880, UDI/DI 40195327153671 (each), 10195327153670 (case), Lot Numbers: 24ABE284;
23) REF DYNJ83158, UDI/DI 40195327236886 (each), 10195327236885 (case), Lot Numbers: 23LBU511;
24) REF DYNJ84083, UDI/DI 40195327332236 (each), 10195327332235 (case), Lot Numbers: 23LBL823;
25) REF DYNJ900289J, UDI/DI 40195327554034 (each), 10195327554033 (case), Lot Numbers: 24ABS131;
26) REF DYNJ900289J, UDI/DI 40195327554034 (each), 10195327554033 (case), Lot Numbers: 24ABE249;
27) REF DYNJ902626G, UDI/DI 40195327214334 (each), 10195327214333 (case), Lot Numbers: 24ABU280;
28) REF DYNJ903264A, UDI/DI 40889942632566 (each), 10889942632565 (case), Lot Numbers: 23LBF682;
29) REF DYNJ903428J, UDI/DI 40195327575060 (each), 10195327575069 (case), Lot Numbers: 24CBI692;
30) REF DYNJ903428J, UDI/DI 40195327575060 (each), 10195327575069 (case), Lot Numbers: 24ABS337;
31) REF DYNJ905769, UDI/DI 40193489507998 (each), 10193489507997 (case), Lot Numbers: 24ABS137;
32) REF DYNJ907056C, UDI/DI 40195327276875 (each), 10195327276874 (case), Lot Numbers: 24ABA207;
33) REF DYNJ908132, UDI/DI 40193489981521 (each), 10193489981520 (case), Lot Numbers: 24CBA800;
34) REF DYNJCH500, UDI/DI 40884389900421 (each), 10884389900420 (case), Lot Numbers: 23LBP611
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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 | 2740 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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