Z-1096-2024Class I
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-11-15 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT... 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-1096-2024
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYKE1892A, d) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G, e) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I, f) FREQUENT DAILY VAD, REF DYNDC3184, g) IMPLANTED VASCULAR ACCESS, REF DYNDC2842, h) INFANT COARTATION PACK, REF DYNJ54822D, i) INFANT OPEN HEART PUMP, REF DYNJ904068D, j) INFUSA PORT DRESSING KIT, REF DYNDC3192, k) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165, l) LVAD DRIVELINE MANAGEMENT KIT, REF DM1165B, m) OPEN HEART ACCESSORY CDS, REF CDS984289K, n) PACEMAKER PK SHSC-LF, REF DYNJ46785C, o) PERICARDIAL KIT, REF DYNDA2212B, p) PK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B, q) PUH PERCUTANEOUS ECMO, REF DYNJ907554A, r) PUH PERCUTANEOUS ECMO, REF DYNJ907554C
- Product code
- OEZ Cardiovascular Procedure 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].
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Product codes and lots
- a) REF DYNDC3106, UDI/DI 40193489913270 (case), 10193489913279 (unit), Lot Numbers: 21LBT706, 22CBE273; b) REF DYKE1346D, UDI/DI 40195327114085 (case), 10195327114084 (unit), Lot Numbers: 22GBO510, 23BBG861, 23CBM313, 23EBN617, 23FBU655, 23GBR877, 23IBH963; c) REF DYKE1892A, UDI/DI 40195327430963 (case), 10195327430962 (unit), Lot Numbers: 10195327430962; d) REF DYKE1648G, UDI/DI 40195327007127 (case), 10195327007126 (unit), Lot Numbers: 22BBY253, 22DBG793, 22EBM485, 22GBY046, 22JBQ585, 22LBJ398, 23CBG974; e) REF DYKE1648I, UDI/DI 40195327351541 (case), 10195327351540 (unit), Lot Numbers: DYKE1648I; f) REF DYNDC3184, UDI/DI 40195327034093 (case), 10195327034092 (unit), Lot Numbers: DYNDC3184; g) REF DYNDC2842, UDI/DI 40193489342568 (case), 10193489342567 (unit), Lot Numbers: DYNDC2842; h) REF DYNJ54822D, UDI/DI 40195327151813 (case), 10195327151812 (unit), Lot Numbers: i) REF DYNJ904068D, UDI/DI 22DMI181, 22GMH542, 23FMG372, 23GMC127; j) REF DYNDC3192, UDI/DI 40195327153251 (case), 10195327153250 (unit), Lot Numbers: 23BMF718, 23CME669, 23FMJ514, 23GMH712, 23IMA898; k) REF DM1165, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers: DYNDC3192; l) REF DM1165B, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers: 23BBA069, 23CBR900, 23DBR127, 23EBP048, 23GBF718, 23HBN448, 23JBB725, 23JBP425; m) REF CDS984289K, UDI/DI 40195327067244 (case), 10195327067243 (unit), Lot Numbers: 22FBX071, 22JBT625, 22LBQ630, 22OBI364, 23ABP719, 23CBI370, 23FBP065, 23FBV540; n) REF DYNJ46785C, UDI/DI 40888277789389 (case), 10888277789388 (unit), Lot Numbers: 22CBY383, 22HBI240, 22JBS870, 22LBR066, 23ABC131, 23BBJ268, 23BBK356, 23CBS913; o) REF DYNDA2212B, UDI/DI 20193489197386 (case), 10193489197389 (unit), Lot Numbers: 22ILA769, 22LLA799, 23BLB093, 23ELA493; p) REF DYNJ44087B, UDI/DI 40195327346585 (case), 10195327346584 (unit), Lot Numbers: 23BBR837, 23EBF536, 23FBL664, 23HBQ739, 23IBF826, 23JBR527, 23KBA577; q) REF DYNJ907554A, UDI/DI 40195327024636 (case), 10195327024635 (unit), Lot Numbers: DYNJ907554A; r) REF DYNJ907554C, UDI/DI 40195327183838 (case), 10195327183837 (unit), Lot Numbers: 22IBF009, 22IBF810, 23ABS408, 23DBE286
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1090-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1091-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1092-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1093-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1094-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1095-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1096-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1097-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1098-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1099-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1100-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1101-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1102-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1103-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1104-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1105-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1106-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1107-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1108-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1109-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1110-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1111-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1112-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1113-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1114-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1115-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1116-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1117-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1118-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1119-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1120-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1121-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1122-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1123-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1124-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1125-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1126-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1127-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1128-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1129-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1130-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1131-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1132-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1133-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1134-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1135-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1136-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1137-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1138-2024 | Class I | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.