510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1112-2024Class I

Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF...

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-11-15 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d)... on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1112-2024
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
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;
Product code
LRP Tray, Surgical
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.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
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 [email protected].
Quantity in commerce
21154 units
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Product codes and 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: 2022061380, 2022061480, 2022082280; j) REF DYNDA2660A, UDI/DI 00653160351897 (case), 10653160351894 (unit), Lot Numbers: 2022042580, 2022050280, 2022082280; k) REF DYNDH1650, UDI/DI 20193489110866 (case), 10193489110869 (unit), Lot Numbers: 2022012050; l) REF DYNDC2816C, UDI/DI 00653160348309 (case), 10653160348306 (unit), Lot Numbers: 2022041880; m) REF EBSI1302A, UDI/DI 20193489111894 (case), 10193489111897 (unit), Lot Numbers:2022020250, 2022022880, 2022082280; n) REF DYNDC3188, UDI/DI 00653160348828 (case), 10653160348825 (unit), Lot Numbers: 2022012450; o) REF DYNDA2659A, UDI/DI 00653160351880 (case), 10653160351887 (unit), Lot Numbers: 2022042850; p) REF DYNDS1085A, UDI/DI 40080196778691 (case), 10080196778690 (unit), Lot Numbers: 2022041150, 2022051350, 2022053150

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1112-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1090-2024Class IOngoingVoluntary: Firm initiated
Z-1091-2024Class IOngoingVoluntary: Firm initiated
Z-1092-2024Class IOngoingVoluntary: Firm initiated
Z-1093-2024Class IOngoingVoluntary: Firm initiated
Z-1094-2024Class IOngoingVoluntary: Firm initiated
Z-1095-2024Class IOngoingVoluntary: Firm initiated
Z-1096-2024Class IOngoingVoluntary: Firm initiated
Z-1097-2024Class IOngoingVoluntary: Firm initiated
Z-1098-2024Class IOngoingVoluntary: Firm initiated
Z-1099-2024Class IOngoingVoluntary: Firm initiated
Z-1100-2024Class IOngoingVoluntary: Firm initiated
Z-1101-2024Class IOngoingVoluntary: Firm initiated
Z-1102-2024Class IOngoingVoluntary: Firm initiated
Z-1103-2024Class IOngoingVoluntary: Firm initiated
Z-1104-2024Class IOngoingVoluntary: Firm initiated
Z-1105-2024Class IOngoingVoluntary: Firm initiated
Z-1106-2024Class IOngoingVoluntary: Firm initiated
Z-1107-2024Class IOngoingVoluntary: Firm initiated
Z-1108-2024Class IOngoingVoluntary: Firm initiated
Z-1109-2024Class IOngoingVoluntary: Firm initiated
Z-1110-2024Class IOngoingVoluntary: Firm initiated
Z-1111-2024Class IOngoingVoluntary: Firm initiated
Z-1112-2024Class IOngoingVoluntary: Firm initiated
Z-1113-2024Class IOngoingVoluntary: Firm initiated
Z-1114-2024Class IOngoingVoluntary: Firm initiated
Z-1115-2024Class IOngoingVoluntary: Firm initiated
Z-1116-2024Class IOngoingVoluntary: Firm initiated
Z-1117-2024Class IOngoingVoluntary: Firm initiated
Z-1118-2024Class IOngoingVoluntary: Firm initiated
Z-1119-2024Class IOngoingVoluntary: Firm initiated
Z-1120-2024Class IOngoingVoluntary: Firm initiated
Z-1121-2024Class IOngoingVoluntary: Firm initiated
Z-1122-2024Class IOngoingVoluntary: Firm initiated
Z-1123-2024Class IOngoingVoluntary: Firm initiated
Z-1124-2024Class IOngoingVoluntary: Firm initiated
Z-1125-2024Class IOngoingVoluntary: Firm initiated
Z-1126-2024Class IOngoingVoluntary: Firm initiated
Z-1127-2024Class IOngoingVoluntary: Firm initiated
Z-1128-2024Class IOngoingVoluntary: Firm initiated
Z-1129-2024Class IOngoingVoluntary: Firm initiated
Z-1130-2024Class IOngoingVoluntary: Firm initiated
Z-1131-2024Class IOngoingVoluntary: Firm initiated
Z-1132-2024Class IOngoingVoluntary: Firm initiated
Z-1133-2024Class IOngoingVoluntary: Firm initiated
Z-1134-2024Class IOngoingVoluntary: Firm initiated
Z-1135-2024Class IOngoingVoluntary: Firm initiated
Z-1136-2024Class IOngoingVoluntary: Firm initiated
Z-1137-2024Class IOngoingVoluntary: Firm initiated
Z-1138-2024Class IOngoingVoluntary: Firm initiated