Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRA...
Reason for Recall / Hazard
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Product Description & Identification
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A 7) SPINE PACK HC, Model Number: DYNJ84272
Affected Products
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A 7) SPINE PACK HC, Model Number: DYNJ84272
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98599 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | 1) DYNJ32841F, UDI-DI: 10195327037796(each), 40195327037797(case), Lot Number: 24CBF407; 2) DYNJ46069D, UDI-DI: 10193489493184(each), 40193489493185(case), Lot Number: 24KBG704; 3) DYNJ51935A, UDI-DI: 10889942735549(each), 40889942735540(case), Lot Number: 24BME364; 4) DYNJ68902A, UDI-DI: 10193489870411(each), 40193489870412(case), Lot Number: 24BMC999; 5) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 22KBJ690; 6) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23BBD696; 7) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23DBG588; 8) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23FBD221; 9) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23GBN050; 10) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23IBB710; 11) DYNJ80679A, UDI-DI: 10195327273705(each), 40195327273706(case), Lot Number: 23LBM277; 12) DYNJ80679A, UDI... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 2609 units |
| Reason for recall | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260225 |
| Initial firm notification | Letter |
| Center classification date | 20260417 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.