—#201480

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

FDA product code: MCY — Wound Dressing Kit
Device class: Class 2
Medical specialty: General Hospital
Affected 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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Timeline

Recall initiated: 2023-05-18
Posted by FDA: 2023-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201480. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.