Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ688
Summary
The FDA issued a Class I for Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL0 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Ch.
Details
Source
Device Recall
External ID
Z-1126-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
Product Description
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e) E-BLEPH CDS, REF CDS983585G; f) EYE CDS, REF CDS983916G; g) EYE KIT, REF DYKM2222; h) EYE PLASTIC PACK, REF DYNJ47859C; i) K PACK, REF LYN030KAGVD; j) OCULOPLASTY PACK, REF DYNJ64572A; k) OL OCULAR, REF DYNJ906183J; l) OL OCULAR, REF DYNJ906183K; m) P M CATARACT, REF DYNJ44917G; n) P M CATARACT, REF DYNJ44917I; o) P PACK, REF LYN030POGVD; p) R VITRECTOMY, REF EYP087W; q) VITRECTOMY PACK, REF DYNJ68884B
Lot/Code Info: a) REF VAL011CTASD, UDI/DI 40195327152032 (case), 10195327152031 (unit), Lot Numbers: 22LBB812, 22LBH455; b) REF DYNJ68875F, UDI/DI 40195327382125 (case), 10195327382124 (unit), Lot Numbers: 23FBQ273, 23GBS122, 23GBS486, 23HBP752; c) REF DYNJ54869F, UDI/DI 40195327407286 (case), 10195327407285 (unit), Lot Numbers: 23FBQ273, 23GBS122, 23GBS486, 23HBP752; d) REF DYNJ44917L, UDI/DI 40195327472604 (case), 10195327472603 (unit), Lot Numbers: 23HBS811; e) REF CDS983585G, UDI/DI 40193489460781 (case), 10193489460780 (unit), Lot Numbers: 22DBI589, 22HBA111, 22JBQ351, 23EBG770; f) REF CDS983916G, UDI/DI 40193489803861 (case), 10193489803860 (unit), Lot Numbers: 22CBV428, 22GBP859, 22HBP383, 23EBP259, 23GBG620, 23IBS207, 23JBW354; g) REF DYKM2222, UDI/DI 40195327337255 (case), 10195327337254 (unit), Lot Numbers: 23DBI071; h) REF DYNJ47859C, UDI/DI 40193489916066 (case), 10193489916065 (unit), Lot Numbers: 23EBA347; i) REF LYN030KAGVD, UDI/DI 40193489956574 (case), 10193489956573 (unit), Lot Numbers: 22ABH632, 22ABW357, 22CBL660, 22IBS624; j) REF DYNJ64572A, UDI/DI 40195327112555 (case), 10195327112554 (unit), Lot Numbers: 22GBL794; k) REF DYNJ906183J, UDI/DI 40195327279449 (case), 10195327279448 (unit), Lot Numbers: 22LMC016, 22LMH698, 23AME088, 23AMF669, 23BMH365, 23CMB182, 23EMA555; l) REF DYNJ906183K, UDI/DI 40195327385522 (case), 10195327385521 (unit), Lot Numbers: 23FMC104, 23FME336, 23GMD288, 23HMH680; m) REF DYNJ44917G, UDI/DI 40195327031481 (case), 10195327031480 (unit), Lot Numbers: 22BBV644; n) REF DYNJ44917I, UDI/DI 40195327156375 (case), 10195327156374 (unit), Lot Numbers: 22FBN595, 22IBK002; o) REF LYN030POGVD, UDI/DI 22ABM649, 22ABW358, 22BBK347, 22CBT855, 22EBR210, 22HBR247, 22KBH816, 22LBA956, 22OBF733, 23ABB019, 23BBQ119; p) REF EYP087W, UDI/DI 50653160050221 (case), 00653160050226 (unit), Lot Numbers: 40195327037254 (case), 10195327037253 (unit), Lot Numbers: 22CBF187, 22EBE045, 22FBO783, 22GBZ358, 22IBF001, 22JBC220, 22KBN864, 22OBE478, 23ABG110, 23BBR173, 23DBH202; q) REF DYNJ68884B, UDI/DI 40195327059010 (case), 10195327059019 (unit), Lot Numbers: 22GBG399
Quantity Affected: 5724 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.
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-15
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 205 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1126-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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