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. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
Affected Products
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 99062 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | DYNJ905153J UDI-DI 10193489395464 Lots 21HBD986 21HBO570 21JBK103 21LBC610 22BBV026 22CME902 22GMG562 DYNJ905153K UDI-DI 10195327187866 Lots 22IMF393 22JMG893 23AMG164 23BMB570 DYNJ905153L UDI-DI 10195327405519 Lots 23FME792 23GMD683 23JMF608 23JMG151 DYNJ49593A UDI-DI 10889942275700 Lot 21FBM893 DYNJ46550K UDI-DI 10195327466992 Lot 24CMB215 DYNJ905157G UDI-DI 10193489397420 Lots 21BBG946 21DBD729 21EBO606 21HBN881 21IBE897 21KBA400 21KBO309 21LBC591 21LBG289 22CBV171 22DMI216 22EMH096 22FMC402 22GMG222 22OBE713 DYNJ905157I UDI-DI 10195327219925 Lots 22LMA455 22LMG933 DYNJ905157J UDI-DI 10195327406004 Lots 23GMB987 23IMA700 DYNJ56930B UDI-DI 10193489631289 Lot 24BBD644 DYNJ905160J UDI-DI 10193489908954 Lots 21GBT443 21HBN882 21JBA979 21KBA397 21KBA398 21LBH668 22CBV042 22DMI217 22EMB282 22EME050 22GMG599 22NBB158 DYNJ905160K UDI-D... [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.