Recall Z-1308-2018
C.R. Bard, Inc. · initiated September 14, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
Codes / lots: 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…
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 taken
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.
Details
- Recall number
- Z-1308-2018
- Initiated
- September 14, 2017
- Posted by FDA
- April 4, 2018
- Terminated
- November 5, 2019
- Product code
- EZD – Catheter, Straight
- Quantity
- 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
- Recalling firm
- C.R. Bard, Inc., Covington, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1307-2018 Class II | HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each…Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were… | 09/14/2017Terminated |
| Z-1309-2018 Class II | Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each…Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were… | 09/14/2017Terminated |