Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Reason for Recall / Hazard
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Product Description & Identification
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ37389O CATH PACK DYNJ62595A DYNJ69997 EP DRAPE PACK-LF DYNJ47645B HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918A INTERVENTIONAL PACK DYNJ56666C INTERVENTIONAL RAD PACK DYNJ44100L INTERVENTIONAL RADIOLOGY PACK DYNJ43664 INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AF OR HYBRID-MRMC DYNJ907758A VMA TRAY DYNJ62376A
Affected Products
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ37389O CATH PACK DYNJ62595A DYNJ69997 EP DRAPE PACK-LF DYNJ47645B HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918A INTERVENTIONAL PACK DYNJ56666C INTERVENTIONAL RAD PACK DYNJ44100L INTERVENTIONAL RADIOLOGY PACK DYNJ43664 INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AF OR HYBRID-MRMC DYNJ907758A VMA TRAY DYNJ62376A
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 99062 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | DYNJ47665D UDI-DI 10193489952827 Lots 21HBJ571 21JBD819 21LBA976 22BBP310 22CBW541 22CMH003 22DMD476 22EMA241 22FMF056 22HMC694 22HME818 22IMC158 22IMG796 22JMD311 22LMD944 22NBC196 23AMB219 DYNJ30565D UDI-DI 10193489905205 Lots 21FDB653 21GDB275 DYNJ0854485V UDI-DI 10195327096885 Lots 22CMB440 22EMF763 22HMA699 22HMG186 22IMD134 22LME930 23BMC883 23CMB807 23CMI020 DYNJ28082D UDI-DI 10193489268676 Lots 21ABN806 21BBP110 21DBL217 21EBS784 21FBU514 DYNJ28082F UDI-DI 10193489949452 Lots 21HBM290 21IBQ174 21KBO096 21KBO098 DYNJ67349 UDI-DI 10193489895728 Lots 23JMA721 24BMF147 DYNJ57874C UDI-DI 10193489976618 Lot 24ABM611 DYNJSCL100 UDI-DI 10884389625583 Lot 24ABM801 DYNJSCL300 UDI-DI 10884389625606 Lot 24ABM802 DYNJ50779F UDI-DI 10193489436068 Lots 21DME914 21EMF097 21GMB502 21JMA420 22BMA533 22BMB246 22DMA002 22DMD984 22DMI... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 113, 843 kits |
| Reason for recall | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260227 |
| Initial firm notification | Letter |
| Center classification date | 20260625 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.