Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Reason for Recall / Hazard
Unapproved design changes to the products outside of the 510(k) clearance.
Product Description & Identification
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G
Affected Products
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF DYNJ87052 BASIC PACK DYNJ83976 BASIC SET UP PACK DYNJ80700 CORONARY ANGIOGRAPHY PACK (N) DYNJ42136B CSTM ANGIO KIT - S VASC1109 CV PACK DYNJ46301C DR F PACK DYNJ41253B ENSEMBLE HEMORROIDES DYNJ56311A G TAVR PACK DYNJ61006 IR MINOR PACK DYNJ44139C MAJOR PLUS PACK DYNJ905160N MAXIMUM BARRIER BUNDLE PACK DYNJ35216C PCI PACK TBRHSC-LF DYNJ41941D PERC PACK-LF DYNJ0774759P PERIPHERAL ANGIOGRAPHY PK DYNJ42094B PROCEDURE PACK DYNJ55063B PTCA PACK DYNJ55359B ROBOTIC PACK DYNJ908706C SPECIAL PROCEDURES TRAY DYNJ41174A SYRINGE WIRE KIT SANFORD SAMPC0644 WPH EP PACK DYNJ62745 X-RAY PACK DYNJ44295G
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98601 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | DYNJ87052 UDI-DI 10198459005121 (EA) 40198459005122 (CS) LOTS 24FLA345 24FLA915 24HLB029 DYNJ83976 UDI-DI 10195327323196 (EA) 40195327323197 (CS) LOTS 24ABO128 DYNJ80700 UDI-DI 10195327066925 (EA) 40195327066926 (CS) LOTS 24BBD119 DYNJ42136B UDI-DI 10889942825288 (EA) 40889942825289 (CS) LOTS 23EMC679 24BMC063 24BMF939 24DMH398 24FMB963 24GMH870 24HMI957 24JMB273 24KMI914 VASC1109 UDI-DI 10889942779079 (EA) 40889942779070 (CS) LOTS 20EBW196 20FBR136 20HBV757 20JBC396 21ABE357 21ABT166 21BBN949 21CBS148 21EBB385 21KBD389 21LBD078 22BBV291 22DBN021 22EBO307 22GBZ351 22JBD956 23FBJ696 23HBR604 23IBF895 24JBK913 24KBR194 DYNJ46301C UDI-DI 10193489527889 (EA) 40193489527880 (CS) LOT 23LMH904 DYNJ41253B UDI-DI 10888277958173 (EA) 40888277958174 (CS) LOT 24ABP897 DYNJ56311A UDI-DI 10193489360127 (EA) 40193489360128 (CS) LOT 24ABR871 DYNJ61006 UDI-DI 10193489... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 270,311 total |
| Reason for recall | Unapproved design changes to the products outside of the 510(k) clearance. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260227 |
| Initial firm notification | Letter |
| Center classification date | 20260417 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.