Class 2 Device Recall Magic 3 Intermittent Catheters

• Date Initiated by Firm: September 14, 2017
• Date Posted: April 04, 2018
• Recall Status: Terminated on November 05, 2019
• Recall Number: Z-1308-2018
• Recall Event ID: 78642
• 510(K)Number: K000723 K122785
• Product Classification: Catheter, straight - Product Code EZD
• Product: Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
• 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
• Recalling Firm/ Manufacturer: C.R. Bard, Inc.; 8195 Industrial Blvd NE; Covington GA 30014-1497
• For Additional Information Contact: BMD Recall Coordinator; 800-793-8110
• Manufacturer Reason for Recall: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
• FDA Determined Cause: Process control
• Action: A notification letter was sent to four hundred and fourteen (414) consignees via Federal Express on September 15, 2017. The letter explained the problem and requested return of the product. Distributors were directed to cease distribution of the recalled products and notify their customers of the recall.
• Quantity in Commerce: 10,949,013 units in total
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EZD