| | 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-0164-2025 |
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| Recall Event ID |
95415 |
| Product Classification |
Foley catheter kit (excludes HIV testing) - Product Code PPB
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| Product | Medline brand medical procedure convenience kits, labeled as:
a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S;
b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS;
c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;
d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;
e) TRAY FOL LATX UM COUD 18FR MF, REF DYND150218CS;
f) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S;
g) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S;
h) TRAY FOLEY SIL 16FR 10ML W/UM, REF DYND150816;
i) TRAY FOL SIL UM COUD 16FR MF, REF DYND150816CS;
j) TRAY FOL SIL 16FR 10ML W/UM MF, REF DYND150816S;
k) TRAY FOL SIL UM COUD 18FR MF, REF DYND150818CS;
l) TRAY FOL SIL 18FR 10ML W/UM MF, REF DYND150818S |
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| Code Information |
a) REF DYND150200S, UDI/DI 40195327387885 (each), 10195327387884 (case), Lot Numbers: 23LBK182;
b) REF DYND150216CS, UDI/DI 40195327388059 (each), 10195327388058 (case), Lot Numbers: 23LBK183;
c) REF DYND150216S, UDI/DI 40195327387366 (each), 10195327387365 (case), Lot Numbers: 23LBO854;
d) REF DYND150216S, UDI/DI 40195327387366 (each), 10195327387365 (case), Lot Numbers: 23LBL067;
e) REF DYND150218CS, UDI/DI 40195327388066 (each), 10195327388065 (case), Lot Numbers: 23LBL068;
f) REF DYND150218S, UDI/DI 40195327388004 (each), 10195327388003 (case), Lot Numbers: 23LBP852;
g) REF DYND150218S, UDI/DI 40195327388004 (each), 10195327388003 (case), Lot Numbers: 23KBK538;
h) REF DYND150816, UDI/DI 40195327043064 (each), 10195327043063 (case), Lot Numbers: 23KBE406;
i) REF DYND150816CS, UDI/DI 40195327149919 (each), 10195327149918 (case), Lot Numbers: 23KBU812;
j) REF DYND150816S, UDI/DI 40195327149711 (each), 10195327149710 (case), Lot Numbers: 24ABA832;
k) REF DYND150818CS, UDI/DI 40195327149926 (each), 10195327149925 (case), Lot Numbers: 23LBH302;
l) REF DYND150818S, UDI/DI 40195327149889 (each), 10195327149888 (case), Lot Numbers: 23KBF923
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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 | 8830 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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