Recall Z-1112-2024
MEDLINE INDUSTRIES, LP - Northfield · initiated November 15, 2023
Class I – dangerous or defective products that could cause serious health problems or death
Product
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF UVT840A g) BRONCHOALVEOLAR LAVAGE PACK, REF DYNDA2369A; h) CENTRAL LINE NEEDLELESS CONNECTOR KIT, REF DYNDC2869B; i) CVC STERILE CAP CHANGE KIT, REF DT20900A; j) DOUBLE VALVE CHANGE KIT, REF DYNDA2660A; k) KIDNEY BIOPSY PACK, REF DYNDH1650; l) PORT ACCESS INFUSION KIT - 0.75IN NEEDLE, REF DYNDC2816C; m) PORT ACCESS KIT, REF EBSI1302A; n) SHORT TERM INFUSAPORT ACCESS KIT, REF DYNDC3188; o) SINGLE VALVE CHANGE KIT, REF DYNDA2659A; p) SUTURE TRAY, REF DYNDS1085A;
Codes / lots: a) REF SUT13935, UDI/DI 40193489440714 (case), 10193489440713 (unit), Lot Numbers: 23GBO782, 23GBP869, 23HBA879, 23HBX374; b) REF SUT21215, UDI/DI 653160325645 (case), 10653160325642 (unit), Lot Numbers: 22EBB078, 22FBE772, 22GBJ917, 22HBN681, 22HBW656, 22JBB835, 23ABL668, 23FBT868, 23GBK697, 23HBU987; c) REF SUT15380, UDI/DI 10653160203698 (case), 653160203691 (unit), Lot Numbers: 22EBI572, 22FBK706, 22GBI140, 22GBZ790, 22JBT097, 22KBW287, 22LBS262, 23DBB365, 23EBB439, 23EBS520, 23FBV416, 23HBV213; d) REF SUT19005, UDI/DI 653160271454 (case), 10653160271451 (unit), Lot Numbers: 23CBV894, 23EBM160, 23FBI594, 23GBK013, 23HBW722; e) REF SUT13535, UDI/DI 40193489440271 (case), 10193489440270 (unit), Lot Numbers: 22FBG265, 22FBU120, 22HBK650, 22LBS268, 23CBH315, 23EBH269, 23HBU983; f) REF UVT840A, UDI/DI 653160292008 (case), 10653160292005 (unit), Lot Numbers: 22ABH461, 22ABJ736; g) REF DYNDA2369A, UDI/DI 00653160352160 (case), 10653160352167 (unit), Lot Numbers: 2022051050, 2022072750; h) REF DYNDC2869B, UDI/DI 20193489111719 (case), 10193489111712 (unit), Lot Numbers: 2021121750, 2022010450; i) REF DT20900A, UDI/DI 00653160353211 (case), 10653160353218 (unit), Lot Numbers:…
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-1112-2024
- Initiated
- November 15, 2023
- Posted by FDA
- February 25, 2024
- Product code
- LRP – Tray, Surgical
- Quantity
- 21154 units
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1090-2024 Class I | MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1091-2024 Class I | MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as:…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1092-2024 Class I | MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1093-2024 Class I | MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350AMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1094-2024 Class I | MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1095-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1096-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1097-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1098-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1099-2024 Class I | Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1100-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1101-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1102-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1103-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1104-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1105-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1106-2024 Class I | MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1107-2024 Class I | Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1108-2024 Class I | Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1109-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1110-2024 Class I | Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1111-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1113-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1114-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1115-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1116-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1117-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1118-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1119-2024 Class I | Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b)…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |
| Z-1120-2024 Class I | Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF…Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of… | 11/15/2023Open, Classified |