Class I Recall

Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1

Summary

The FDA issued a Class I for Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ 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-1127-2024

Action Date

2024-03-06

Status

Ongoing

Product Description

Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F; g) EXTREMITY IV, REF CMPJ06040D; h) EXTREMITY IV, REF CMPJ06040F; i) EXTREMITY PROCEDURE, REF CDS981656I; j) FACIAL PLASTY PACK, REF DYNJ55335D; k) FOOT PROCEDURE, REF CDS981659I; l) FOOT PROCEDURE, REF CDS981659J; m) HAND, REF DYNJ902002J; n) HAND PACK, REF DYNJ35744A; o) HAND PACK, REF DYNJ68873C; p) HAND PACK, REF DYNJ46211K; q) KNEE ARTHROSCOPY CDS, REF CDS941004C; r) KNEE PACK, REF DYNJ68512; s) LACERATION TRAY, REF SUT21580; t) LOWER EXTREMITY, REF DYNJ907121F; u) LOWER EXTREMITY, REF DYNJ46222M; v) LOWER EXTREMITY PACK, REF DYNJ67216C; w) LOWER EXTREMITY PACK, REF DYNJ67216D; x) PACK,POSTERIOR SPINAL FUSION, REF DYNJ906892; y) PODIATRY PACK, REF DYNJ68347A; z) PODIATRY PACK, REF DYNJ68347B; aa) PODIATRY PACK-LF, REF DYNJ34648D; bb) POSTERIOR PACK, REF DYNJ64576A; cc) SHOULDER, REF DYNJ903011J; dd) SHOULDER ARTHROTOMY PROCEDURE, REF CDS981658G; ee) SHOULDER KIT, REF DYNJ907705D; ff) SMALL HAND CDS, REF DYNJ902002G; gg) SMALL HAND CDS, REF DYNJ902002I; hh) SMALL HAND PACK, REF CMPJ06038F; ii) SMALL HAND PACK, REF CMPJ06038G; jj) TOTAL KNEE, REF DYNJ909159; kk) TOTAL KNEE CDS, REF CDS982823P; ll) TOTAL KNEE CDS, REF CDS982823Q; mm) TRIGGER FINGER KIT, REF DYNJ68406; nn) UPPER EXTREMITY, REF DYNJ907130C

Lot/Code Info: a) REF DYNJ64814A, UDI/DI 40195327112807 (case), 10195327112806 (unit), Lot Numbers: 22FBD779, 22JBN895; b) REF DYNDH1629, UDI/DI 40193489917360 (case), 10193489917369 (unit), Lot Numbers: 22ABP606; c) REF DYNJ48587A, UDI/DI 40889942313106 (case), 10889942313105 (unit), Lot Numbers: 22JBQ342, 23ABL345, 23CBJ954, 23DBK384, 23FBQ607; d) REF CDS983313I, UDI/DI 40193489424540 (case), 10193489424539 (unit), Lot Numbers: 22DDA444, 22EDB075, 23ADB093, 23CDC442, 23DDA819, 23EDC367; e) REF DYNJ902004D, UDI/DI 40193489351782 (case), 10193489351781 (unit), Lot Numbers: 22FBR327, 22JBQ099; f) REF DYNJ902004F, UDI/DI 40195327257591 (case), 10195327257590 (unit), Lot Numbers: 23BBF818, 23BBN981, 23HBL676, 23IBA162, 23IBJ945; g) REF CMPJ06040D, UDI/DI 40193489351782 (case), 10193489351781 (unit), Lot Numbers: 22EBU873, 22IBA206; h) REF CMPJ06040F, UDI/DI 40195327257591 (case), 10195327257590 (unit), Lot Numbers: 23ABN951, 23ABU853, 23GBV583, 23GBW733, 23HBK120; i) REF CDS981656I, UDI/DI 40193489433884 (case), 10193489433883 (unit), Lot Numbers: 22BDB050, 22EDB527, 22FDB578, 23BDA698, 23BDB738, 23EDA039; j) REF DYNJ55335D, UDI/DI 40889942703228 (case), 10889942703227 (unit), Lot Numbers: 23JBB690; k) REF CDS981659I, UDI/DI 40193489433907 (case), 10193489433906 (unit), Lot Numbers: 23BDB207, 23DDA594, 23EDA040, 23FDB570; l) REF CDS981659J, UDI/DI 40195327398508 (case), 10195327398507 (unit), Lot Numbers: 23JBM035; m) REF DYNJ902002J, UDI/DI 40195327516070 (case), 10195327516079 (unit), Lot Numbers: 22DBB588, 23DBA171, 23EBL341, 23FBA124, 23FBU113, 23FBV329, 23GBN600, 23GBQ956, 23JBA529; n) REF DYNJ35744A, UDI/DI 40889942600596 (case), 10889942600595 (unit), Lot Numbers: 22DBB588; o) REF DYNJ68873C, UDI/DI 40195327375691 (case), 10195327375690 (unit), Lot Numbers: 23FBA124, 23FBU113, 23FBV329, 23GBQ956; p) REF DYNJ46211K, UDI/DI 40195327407484 (case), 10195327407483 (unit), Lot Numbers: 23DBA171, 23EBL341, 23GBN600, 23JBA529; q) REF CDS941004C, UDI/DI 40888277507471 (case), 10888277507470 (unit), Lot Numbers: 22ALA255, 22IMA552; r) REF DYNJ68512, UDI/DI 40193489828956 (case), 10193489828955 (unit), Lot Numbers: 21KBI896, 22BBV355, 22EBN387, 22EBP166, 22FBA911, 22FBL484, 22IBO503, 22JBW455, 22KBM697, 22LBN605, 22LBQ786, 23BBB214, 23BBS153, 23EBO560, 23GBN713, 23HBH102, 23JBL709; s) REF SUT21580, UDI/DI 40653160991077 (case), 10653160991076 (unit), Lot Numbers: 23EBL458; t) REF DYNJ907121F, UDI/DI 40195327222087 (case), 10195327222086 (unit), Lot Numbers: 22LBR588; u) REF DYNJ46222M, UDI/DI 40195327437566 (case), 10195327437565 (unit), Lot Numbers: 23HBP767, 23IBW177; v) REF DYNJ67216C, UDI/DI 40195327280674 (case), 10195327280673 (unit), Lot Numbers: 22LLA847, 23CLA146; w) REF DYNJ67216D, UDI/DI 40195327405183 (case), 10195327405182 (unit), Lot Numbers: 23ELA164, 23FLA372; x) REF DYNJ906892, UDI/DI 40193489281461 (case), 10193489281460 (unit), Lot Numbers: 22GBI467, 22GBM602, 22OBH187, 22OBJ425, 22OBK650; y) REF DYNJ68347A, UDI/DI 40193489934107 (case), 10193489934106 (unit), Lot Numbers: 22ABK059, 22BBU107, 22CBS838; z) REF DYNJ68347B, UDI/DI 40195327141197 (case), 10195327141196 (unit), Lot Numbers: 22FBG492, 22FBU866; aa) REF DYNJ34648D, UDI/DI 40193489916165 (case), 10193489916164 (unit), Lot Numbers: 22HBH536; bb) REF DYNJ64576A, UDI/DI 40195327111954 (case), 10195327111953 (unit), Lot Numbers: 22GBL600; cc) REF DYNJ903011J, UDI/DI 40195327437573 (case), 10195327437572 (unit), Lot Numbers: 23IBF175, 23JBS067; dd) REF CDS981658G, UDI/DI 40193489876827 (case), 10193489876826 (unit), Lot Numbers: 22CDC277, 23DDB287; ee) REF DYNJ907705D, UDI/DI 40195327375783 (case), 10195327375782 (unit), Lot Numbers: 23EBU785, 23JBF717, 23KBA709; ff) REF DYNJ902002G, UDI/DI 40193489351737 (case), 10193489351736 (unit), Lot Numbers: 22HBA403, 22HBS428, 22IBE726; gg) REF DYNJ902002I, UDI/DI 40195327257621 (case), 10195327257620 (unit), Lot Numbers: 22LBS865, 23ABO144, 23BBR667, 23DBS266, 23EBT050, 23FBE713, 23HBQ460; hh) REF CMPJ06038F, UDI/DI 40193489351737 (case), 10193489351736 (unit), Lot Numbers: 22EBI104, 22HBO484; ii) REF CMPJ06038G, UDI/DI 40195327257621 (case), 10195327257620 (unit), Lot Numbers: 22KBG879, 22KBU962, 23BBD874, 23DBA902, 23DBK147, 23EBQ126, 23GBQ295; jj) REF DYNJ909159, UDI/DI 40195327280896 (case), 10195327280895 (unit), Lot Numbers: 23EBS908; kk) REF CDS982823P, UDI/DI 40193489402760 (case), 10193489402759 (unit), Lot Numbers: 22OBI091; ll) REF CDS982823Q, UDI/DI 40195327238340 (case), 10195327238339 (unit), Lot Numbers: 23ABT038, 23BBK666, 23EBJ570, 23FBL610, 23HBE191, 23JBD296, 23JBR325; mm) REF DYNJ68406, UDI/DI 40193489440363 (case), 10193489440362 (unit), Lot Numbers: 22OBK988; nn) REF DYNJ907130C, UDI/DI 40193489821636 (case), 10193489821635 (unit), Lot Numbers: 23ABD199

Quantity Affected: 14280 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

MEDLINE INDUSTRIES, LP - Northfield

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-1127-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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