FDA Medical devices recall ·
Medline brand medical procedure convenience kits… recall
- Recall number
- Z-0164-2025
- Date
- (initiated September 4, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 8830 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0164-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.