Z-1308-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 11, 2018
- Initiation Date
- September 14, 2017
- Termination Date
- November 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,949,013 units in total
Product Description
Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
Reason for Recall
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Distribution Pattern
US Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, HI, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Puerto Rico
Code Information
Item # 50612 Lots #'s: JUBQ0995, JUAZ1253, JUBN0527, JUBP0065, JUBP0225, JUBP0675, JUBQ0093, JUBT1089, JUBQ1417, JUBQ1691, JUBR0232, JUAX0761, and JUAY0563 Item # 50614 Lots #'s: 53621355, JUAW0726, JUAW1103, JUAW1105, JUAW1200, JUAW1201, JUAW1209, JUAX0174, JUAX0275, JUAX0276, JUAX0679, JUAX0680, JUAX0745, JUAX0759, JUAY0141, JUAY0163, JUAY0451, JUAY0468, JUAY0587, JUAY0655, JUAY0685, JUAY0911, JUAY0930, JUAZ0126, JUAZ0147, JUAZ1147, JUAZ1157, JUAZ1207, JUAZ1252, JUAZ1275, JUAZ1281, JUBN0049, JUBN0077, JUBN0490, JUBN0526, JUBN0824, JUBN0850, JUBN1022, JUBP0035, JUBP0063, JUBP0194, JUBP0224, JUBP0674, JUBP0699, JUBP1182, JUBP1202, JUBQ0024, JUBQ0039, JUBQ0076, JUBQ0091, JUBQ1023, JUBQ1390, JUBQ1416, JUBQ1673, JUBQ1690, JUBR0256, JUBR0853, JUBR0883, JUBR1245, JUBR1271, JUBR2530, JUBR2531, JUBR2565, JUBS1262, JUBS1291, JUBS1877, JUBS1905, JUBS2411, JUBS2412, JUBS2449, JUBT1055 and JUBU0498 Item # 50616 Lot #'s: JUAX0175, JUAX0176, JUAX0177, JUAX0277, JUAX0681, JUAX0708, JUAX0747, JUAY0142, JUAY0469, JUAY0588, JUAY0664, JUAY0931, JUAZ0148, JUAZ1148, JUAZ1208, JUBN0078, JUBN0491, JUBN0825, JUBN0851, JUBN0999, JUBN1023, JUBP0064, JUBP0701, JUBP1183, JUBP1203, JUBQ0092,J UBQ1024 , JUBQ1368, JUBQ1395, JUBQ1686, JUBR0257, JUBR0373, JUBR0860, JUBR0890, JUBR1272, JUBS0439, JUBS0469, JUBS1263, JUBS2409, JUBS2410, JUBS2447, JUBT0121, JUBT0161 and JUBT0162