PlainRecalls
FDA Devices Critical Class I Ongoing

Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A

Reported: August 14, 2024 Initiated: April 8, 2024 #Z-2443-2024

Product Description

Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A

Reason for Recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Details

Units Affected
1,679,067 units in total
Distribution
Worldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 1,679,067 units in total.
Why was this product recalled?
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 14, 2024. Severity: Critical. Recall number: Z-2443-2024.