—#201376

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338; i) BLOCK KIT-LF, Model Number DYNJRA1287A; j) BLOCK KIT-LF, Model Number PAIN1622A; k) BLOCK KIT-LF, Model Number DYNJRA1543; l) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A; m) PK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D; n) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604; o) BLOCK TRAY, Model Number PAIN1182;

FDA product code: OGJ — Nerve Block Tray
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJRA1220, UDI/DI (EA)10888277795037, UDI/DI (CS)40888277795038; b) Model Number DYNJRA1773, UDI/DI (EA)10193489862973, UDI/DI (CS)40193489862974; c) Model Number DYNJ51107B, UDI/DI (EA)10193489810479, UDI/DI (CS)40193489810470; d) Model Number DYNJ0703127A, UDI/DI (EA)10889942084630, UDI/DI (CS)40889942084631; e) Model Number DYNJ42367B, UDI/DI (EA)10193489211511, UDI/DI (CS)40193489211512; f) Model Number DYNJRA1571, UDI/DI (EA)10193489264739, UDI/DI (CS)40193489264730; g) Model Number DYNJRA0656A, UDI/DI (EA)10889942225118, UDI/DI (CS)40889942225119; h) Model Number DYNJ47338, UDI/DI (EA)10888277900172, UDI/DI (CS)40888277900173; i) Model Number DYNJRA1287A, UDI/DI (EA)10193489773095, UDI/DI (CS)40193489773096; j) Model Number PAIN1622A, UDI/DI (EA)10193489891690, UDI/DI (CS)40193489891691; k) Model Number DYNJRA1543, UDI/DI (EA)10193489217667, UDI/DI (CS)40193489217668; l) Model Number DYNJRA1635A, UDI/DI (EA)10193489367645, UDI/DI (CS)40193489367646; m) Model Number DYNJ0134147D, UDI/DI (EA)10889942937349, UDI/DI (CS)40889942937340; n) Model Number DYNJRA1604, UDI/DI (EA)10193489299816, UDI/DI (CS)40193489299817; o) Model Number PAIN1182, UDI/DI (EA)10889942720927, UDI/DI (CS)40889942720928;

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 #201376. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.