FDA Device Recall Z-1106-2024

MEDLINE INDUSTRIES, LP - Northfield · Northfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H

Lot / serial / GTIN: a) REF DYKE1350D; UDI/DI 40193489339797 (case), 10193489339796 (unit), Lot Numbers: 22FBT089, 22LBN853, 23CBI535, 23DBQ149, 23EBI601; b) REF DYNJ36728C; UDI/DI 40193489265911 (case), 10193489265910 (unit), Lot Numbers: 22BBJ543, 22FBD924, 22HBR956, 23BBF230, 23FBG752; c) REF UVT1170; UDI/DI 40653160991244 (case), 10653160991243 (unit), Lot Numbers: 21LBK307, 22DMH696; d) REF UVT1170H; UDI/DI 40653160991244 (case), 10653160991243 (unit), Lot Numbers: 21LBK307, 22DMH696

Quantity: 1184 units

Reason for recall

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Recall record

Recall number: Z-1106-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Recall initiated: 2023-11-15
Classified by FDA Center: 2024-02-24
FDA published: 2024-03-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Firm location: Northfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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