medical Class II Updated 2023-07-26

MEDLINE INDUSTRIES, LP - Northfield recalls Medline Probe Cover Kits containing sterile Ultrasound Gel,

Recalled Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY, Model Number DYNJ42902B; e) CENTRAL LINE PACK - COMPANION, Model Number DYNJ47215D; f) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717A; g) PK CUST CENTRAL LINE PACK, Model Number DYNJ60586; h) TUNNEL LINE PACK, Model Number DYNJ67990; i) CLOSURE PACK, Model Number DYNJ83054A

Hazard / Issue

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDL1134A, UDI/DI (EA) 10080196994762, UDI/DI (CS)40080196994763; b) Model Number DYNDV2385, UDI/DI (EA) 10193489475593, UDI/DI (CS)40193489475594; c) Model Number DYNJ38885B, UDI/DI (EA) 10193489462333, UDI/DI (CS)40193489462334; d) Model Number DYNJ42902B, UDI/DI (EA) 10888277798007, UDI/DI (CS)40888277798008; e) Model Number DYNJ47215D, UDI/DI (EA) 10888277743021, UDI/DI (CS)40888277743022; f) Model Number DYNJ47717A, UDI/DI (EA) 10193489454529, UDI/DI (CS)40193489454520; g) Model Number DYNJ60586, UDI/DI (EA) 10193489528046, UDI/DI (CS)40193489528047; h) Model Number DYNJ67990, UDI/DI (EA) 10193489462531, UDI/DI (CS)40193489462532; i) Model Number DYNJ83054A, UDI/DI (EA) 10195327310516, UDI/DI (CS)40195327310517
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