Merit Medical Systems, Inc.: Allwell Angioplasty Pack REF: IS-30-B1/B

Hazard

Inflation device handle may detach from the syringe during procedure.

Details from the source

Reason for recall: Inflation device handle may detach from the syringe during procedure. Distribution: Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Br Quantity: 328000 units Lot/code info: UDI:00884450653388/ Lot: I2563105 I2563106 I2565007 I2598114 I2598131 I2607891 I2612499 I2618005 I2623057 I2632527 I2632528 I2639728 I2661908 I2669772 I2669774 I2827091 I2827094 I2844360 I2844361 I2897482 I2897483 I2897484 I2897485 I2924663 I2972425 I2972426 I2972427 I2972428 I2999054 I3014683 I3030198 I3048363 I3055799 I3080949 I3089230 I3099150 I3110034 I3129711 I3129712 I3161408 I3268359 I3268361 I3268362

UPC codes

00884450653388

Source

Official record: FDA (Device enforcement) ↗

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