510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1091-2024Class I

MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH...

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 TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF... 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-1091-2024
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482
Product code
NXA Tracheotomy Care Kit
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
2683387 units
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Product codes and lots
a) REF DYNDJ1129, UDI/DI 40195327391400 (case), 10195327391409 (unit), Lot Numbers: 23EBD895, 23EBD896, 23EBD897, 23GBQ880; b) REF DYNDJ1057A, UDI/DI 40888277204790 (case), 10888277204799 (unit), Lot Numbers: 23ABA019, 23EBM580, 23HBU078; c) REF DYNDA1893A, UDI/DI 40193489866125 (case), 10193489866124 (unit), Lot Numbers: 23CBA077, 23CBI537, 23CBT627, 23DBF373, 23EBM582, 23HBV368, 23JBP946; d) REF DYNDA1482, UDI/DI 40889942131151 (case), 10889942131150 (unit), Lot Numbers: 2022040690, 2022052390, 2022102090, 2023011790

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1091-2024
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