C.R. Bard Inc Recall 92082
Description: HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
C.R. Bard Inc Recall 92082 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1701-2023 |
| Event ID | 92082 |
| Event Description | HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818 |
| Product Type | Devices |
| Distribution | Worldwide |
| Quantity | 308520 devices |
| Recall Reason | Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility. |
| Device Classification | 20230614 |
| Device Code Info | a) REF 71808, Lot Numbers: JUGU9026; b) REF 71810, Lot Numbers: JUGT9154, JUGU9053, JUGV9130, JUGV9133; c) REF 71812, Lot Numbers: JUGT0236, JUGT1689, JUGT2702, JUGU1955, JUGU1968, JUGV9158; d) REF 71814, Lot Numbers: JUGT3326; e) REF 71816, Lot Numbers: JUGU9023; f) REF 71818, Lot Numbers: JUGT0288, JUGU9022 |
| Center Classification Date | 20230608 |
| Recall Initiation Date | 20230420 |
| Recalling Firm | C.R. Bard Inc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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