FDA Device Recall Z-1101-2024

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) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ45175B; g) ENT PACK, REF DYNJ59030A; h) ENT PACK, REF DYNJ83416; i) ENT/EPISTAXIS TRAY, REF MNS2895; j) ENT/EPISTAXIS TRAY, REF MNS2895H; k) HEAD & NECK PACK, REF DYNJ60166C; l) HEAD AND NECK CDS, REF CDS983910K; m) HEAD AND NECK PACK, REF DYNJ68872C; n) HEAD AND NECK PACK, REF DYNJ46216J; o) NASAL, REF CDS984899G; p) NASAL, REF CDS984899I; q) PACK,BRONCHOSCOPY, REF DYNJ65475A; r) SINGLE CENTRAL LINE CAP CHANGE, REF DYNDC2213F; s) T & A, REF CDS984895I; t) T AND A, REF DYNJ36719C; u) T AND A, REF DYNJ906741B; v) T AND A CDS, REF CDS983362C; w) T&A PACK, REF DYNJ33112I; x) TONSIL CDS-LF, REF CDS980272L; y) TRACH CARE KIT, REF DYNDJN001A

Lot / serial / GTIN: a) REF CDS983682F; UDI/DI 40193489852975 (case), 10193489852974 (unit), lot Numbers: 22DDA235, 22GBJ113, 23ABQ437, 23EBS939; b) REF DYKE1718A; UDI/DI 40193489494656 (case), 10193489494655 (unit), Lot Numbers: 22FBU098, 22HBM601, 23ABM389; c) REF DYKE1718B; UDI/DI 40195327240128 (case), 10195327240127 (unit), Lot Numbers: 23DBE977; d) REF DYNDC2214G; UDI/DI 40195327051984 (case), 10195327051983 (unit), Lot Numbers: 22ABP471, 22BBO794, 22OBJ991; e) REF DYNJ55334C; UDI/DI 40889942703211 (case), 10889942703210 (unit), Lot Numbers: 22ABL051, 22EBV190, 22FBS394, 23BBA777, 23GBL169; f) REF DYNJ45175B; UDI/DI 40889942485216 (case), 10889942485215 (unit), Lot Numbers: 22CLB148, 22GLB002; g) REF DYNJ59030A; UDI/DI 40195327026203 (cases), 10195327026202 (unit), Lot Numbers: 22DBR838, 22EBO071, 22JBW765, 23FBF261, 23GBC456, 23HBR618; h) REF DYNJ83416; UDI/DI 40195327265053 (cases), 10195327265052 (unit), Lot Numbers: 22LBF471, 23ABN102, 23BBA471; i) REF MNS2895; UDI/DI 50653160062934 (case), 653160062939 (unit), Lot Numbers: 23BBQ180, 23DBN766, 23EBH195, 23FBE540; j) REF MNS2895H; UDI/DI 50653160062934 (case), 653160062939 (unit), Lot Numbers: 23BBQ180, 23DBN766, 23EBH195, 23FBE540; k) REF DYNJ60166C; UDI/DI 40193489467148 (case), 10193489467147 (unit), Lot Numbers: 23ELB099; l) REF CDS983910K; UDI/DI 40195327256594 (case), 10195327256593 (unit), Lot Numbers: 22JBT244, 23ABP271, 23ABP272, 23ABQ792, 23CBE912, 23DBR779, 23FBB371, 23JBL006, 23JBR337; m) REF DYNJ68872C; UDI/DI 40195327375714 (case), 10195327375713 (unit), Lot Numbers: 23DBC646, 23FBA039, 23GBA604, 23HBZ389, 23JBN556; n) REF DYNJ46216J; UDI/DI 40195327407491 (case), 10195327407490 (unit), Lot Numbers: 23EBF873, 23GBO919, 23GBT576, 23IBE145; o) REF CDS984899G; UDI/DI 40193489983822 (case), 10193489983821 (unit), Lot Numbers: 22CLA789; p) REF CDS984899I; UDI/DI 40195327313297 (case), 10195327313296 (unit), Lot Numbers: 23IBV180; q) REF DYNJ65475A; UDI/DI 40193489974578 (case), 10193489974577 (unit), Lot Numbers: 22DBF905; r) REF DYNDC2213F; UDI/DI 40195327052080 (case), 10195327052089 (unit), Lot number: 22ABM936, 22CMG684, 22EMB991; s) REF CDS984895I; UDI/DI 40193489983815 (case), 10193489983814 (unit), Lot Number: 22FBL382, 22IBD790, 23ABM451, 23DBM334; t) REF DYNJ36719C; UDI/DI 40193489265539 (case), 10193489265538 (unit), Lot Numbers: 21LBA818, 21LBU235, 22BBL912; u) REF DYNJ906741B; UDI/DI 40195327055364 (case), 10195327055363 (unit), Lot Numbers: 22ABF704, 22ABL214, 22BBQ966, 22FBY564, 22GBQ902, 22HMI302, 23AMA387, 23AMI317; v) REF CDS983362C; UDI/DI 40193489267342 (case), 10193489267341 (unit), Lot Numbers: 23ABI733; w) REF DYNJ33112I; UDI/DI 40193489402736 (case), 10193489402735 (unit), Lot Numbers: 22DBO140, 22DBO155, 22JBY668, 23BBT134, 23DBT051, 23EBA549, 23HBI328, 23IBM005; x) REF CDS980272L; UDI/DI 40193489616331 (case), 10193489616330 (unit), Lot Numbers: 22NBC732; y) REF DYNDJN001A; UDI/DI 40193489421614 (case), 10193489421613 (unit), Lot Numbers: 22EBB217, 22FBQ070, 22FBU496

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-1101-2024
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.

‹ All device recalls