Z-2701-2024Class II
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-03-22 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A... on . FDA classified it as Class II and gives the reason as "A slight dimensional variation which has the potential for increased difficulty fitting into outer canister". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2701-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C
- Product code
- OEZ Cardiovascular Procedure Kit
- Reason for recall
- A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- FDA root cause
- Under Investigation by firm
- Action
- Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.
- Quantity in commerce
- 26096 units
- Distribution
- Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
- Product codes and lots
- a) REF DYNJ902752C, UDI/DI 40195327226993 (case), 10195327226992 (unit), Lot Numbers: 22IBA627, 22JBE922, 22JBP917, 22KBJ447, 23BBB611, 23CBC455, 23EBF908, 23FBV764, 23GBW761, 23IBR157; b) REF DYKE1872A, UDI/DI 40195327330027 (case), 10195327330026 (unit), Lot Numbers: 23CBB846, 23CBK197, 23DBK952, 23FBD020, 23FBG375, 23FBJ258, 23FBV848, 23HBA337, 23HBC022, 23IBA872, 23IBL364, 23JBB228, 23JBE437, 23JBE720, 23JBF969, 23JBV002, 23JBV507, 23KBG556, 23KBM618; c) REF DYKE1921A, UDI/DI 40195327488612 (case), 10195327488611 (unit), Lot Numbers: 23HBQ471, 23JBK197, 23LBD048; d) REF DYNJ901681D, UDI/DI 40193489308090 (case), 10193489308099 (unit), Lot Numbers: 22EBC373, 22EBD234, 22EBE775, 22EBF837, 22FBV877, 22GBT729, 23ABA707, 23BBI384, 23FBO404, 23GBO428, 23GBO470, 23JBH973; e) REF DYKE1922A, UDI/DI 40195327487943 (case), 10195327487942 (unit), Lot Numbers: 23IBK378, 23IBM326, 23JBP210, 23KBX462; f) REF DYNJ905515D, UDI/DI 40193489968041 (case), 10193489968040 (unit), Lot Numbers: 22FMB396, 22FMG767, 22IMB116, 22LMA842, 23AMI823, 23GMH322, 23IMC097; g) REF DYNJ902387K, UDI/DI 40195327505852 (case), 10195327505851 (unit), Lot Numbers: 23JBR461, 23KBT452; h) REF DYNJS2035C, UDI/DI 40193489214278 (case), 10193489214277 (unit), Lot Numbers: 22FDA441, 22GDA574, 22JDB543, 22LDB596, 23ADB285
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2694-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2695-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2696-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2697-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2698-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2699-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2700-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2701-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2702-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2703-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2704-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2705-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2706-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2707-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2708-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2709-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2710-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2711-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2712-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2713-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2714-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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