Medline Industries, LP: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO

Hazard

Unapproved design changes to the products outside of the 510(k) clearance.

Details from the source

Reason for recall: Unapproved design changes to the products outside of the 510(k) clearance. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados. Quantity: 270,311 total Lot/code info: DYNJ0373221P UDI-DI 10195327506575 (EA) 40195327506576 (CS) LOTS 24ABR861 DYNJ0516014AI UDI-DI 10198459246234 (EA) 40198459246235 (CS) LOTS 25BME135 25EMI244 DYNJ0545064AA UDI-DI 10195327327385 (EA) 40195327327386 (CS) LOTS 23CMD735 24BMA467 24CME416 24DMG231 24EMI752 24FMD170 24HMD253 24JMC552 24LMA043 25AMJ675 25CMB252 25EMD050 25EMF726 DYNJ0854485X UDI-DI 10195327450366 (EA) 40195327450367 (CS) LOTS 23GMA609 23HMF271 23IMH767 23JMI189 23LMH350 24DMC322 24FMB078 24HMA888 24HMJ182 24LMB120 DYNJ17218R UDI-DI 10195327459642 (EA) 40195327459643 (CS) LOTS 23GDA609 23HDB136 23IDB699 23KDA473 DYNJ28082I UDI-DI 10195327429713 (EA) 40195327429714 (CS) LOTS 23HBC876 23KBE157 24BBC678 24DBN465 24FBQ528 24GBO066 24HBF409 24KBG843 DYNJ30565G UDI-DI 10195327140687 (EA) 40195327140688 (CS) LOTS 22DDB753 22FDB429 22HDB442 22KDA279 22LDB909 23BDB812 23EDA339 23GDA440 23IDA647 23IDB341 23KDB268 24BDA252 24CDB812 24EDC035 24HDC110 24IMA915 24JMI363 24KMG704 24LMF893 DYNJ36752B UDI-DI 10195327226022 (EA) 40195327226023 (CS) LOT 23IMD713 DYNJ37211J UDI-DI 10195327363673 (EA) 40195327363674 (CS) LOTS 24ABL975 24BBM554 24DBA215 24EBF356 24FBR841 24HBF463 24IBV426 24KBC581 24LBM346 DYNJ37389P UDI-DI 10195327201418 (EA) 40195327201419 (CS) LOTS 23DBO927 23FBC559 23GBF169 23GBJ160 23IBM982 DYNJ37389Q UDI-DI 10195327531270 (EA) 40195327531271 (CS) LOTS 23KBL184 23LMC983 23LMG114 24AME115 24BMJ169 24CMB351 24CMI800 24FMH298 24GMH700 24HMH956 24IMI993 24KMF785 24LMF430 DYNJ37485D UDI-DI 10195327397333

UPC codes

10195327506575, 40195327506576, 10198459246234, 40198459246235, 10195327327385, 40195327327386, 10195327450366, 40195327450367, 10195327459642, 40195327459643, 10195327429713, 40195327429714, 10195327140687, 40195327140688, 10195327226022, 40195327226023, 10195327363673, 40195327363674, 10195327201418, 40195327201419, 10195327531270, 40195327531271, 10195327397333, 40195327397334, 10195327531256, 40195327531257, 10195327286767, 40195327286768, 10195327265182, 40195327265183, 10195327427276, 40195327427277, 10198459252471, 40198459252472, 10195327355210, 40195327355211, 10195327535810, 40195327535811, 10195327299996, 40195327299997

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.