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. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ68063 DYNJ68845 DYNJ68845A DYNJ68845B NEURO CERVICAL PACK DYNJ0101287I DYNJ0101287L NEURO PACK DYNJ82103 DYNJ82103A NEURO TRAY DYNJ67075 DYNJ67075A DYNJ67075B NEURO VASCULAR PACK DYNJ62960B NEURO VP SHUNT PACK-LF DYNJ0843121J DYNJ0843121K NEUROLOGICAL CATH PACK DYNJ63434A DYNJ63434C NEURORADIOLOGY PK DYNJ40420D RADIOLOGY ANGIO MAJOR PACK-LF DYNJ62858A RADIOLOGY NEURO DRAPE PAC DYNJ61449 RRMC ANGIO PACK DYNJ36338B
Affected Products
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK-LF DYNJ0854485S DEEP BRAIN STIMULATION PACK DYNJ0842793G NEURO ACCESSORY PACK DYNJ55385A NEURO ANGIO PACK DYNJ51697B DYNJ56509G DYNJ56509I DYNJ68063 DYNJ68845 DYNJ68845A DYNJ68845B NEURO CERVICAL PACK DYNJ0101287I DYNJ0101287L NEURO PACK DYNJ82103 DYNJ82103A NEURO TRAY DYNJ67075 DYNJ67075A DYNJ67075B NEURO VASCULAR PACK DYNJ62960B NEURO VP SHUNT PACK-LF DYNJ0843121J DYNJ0843121K NEUROLOGICAL CATH PACK DYNJ63434A DYNJ63434C NEURORADIOLOGY PK DYNJ40420D RADIOLOGY ANGIO MAJOR PACK-LF DYNJ62858A RADIOLOGY NEURO DRAPE PAC DYNJ61449 RRMC ANGIO PACK DYNJ36338B
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 99062 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | DYNJ0854485S UDI-DI 10193489250558 Lot 21BMA604 DYNJ0842793G UDI-DI 10195327293666 Lots 22LDA183 23EDB049 23HDC042 23JDA988 24DDA005 DYNJ55385A UDI-DI 10193489762129 Lot 21ALA184 DYNJ51697B UDI-DI 10889942893652 Lots 21ABE325 21CBH476 21DBV407 21HBH690 21JBN408 21LBL194 21VBB105 22DBL109 22EBH117 22FBS410 22JBM660 22LBJ592 22NBG350 23BBR238 23CBH111 23DBN366 23GBE252 23HBP266 DYNJ56509G UDI-DI 10193489832082 Lots 21BBQ398 21BBR321 21CBO123 21DBM014 DYNJ56509I UDI-DI 10193489947113 Lots 21HBI572 21HBK163 DYNJ68063 UDI-DI 10193489872040 Lot 21FBN698 DYNJ68845 UDI-DI 10193489481006 Lot 21JBZ479 DYNJ68845A UDI-DI 10195327058104 Lot 22CBF908 22EBS916 DYNJ68845B UDI-DI 10195327211806 Lot 22HBL865 DYNJ0101287I UDI-DI 10193489434033 Lots 21CDA247 21EDA767 21GDC130 21HDA996 21KDA985 21LDA070 22BDA782 22CDC182 22EDB032 22GDA474 22IDB680 22KDB540 ... [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.