Recall Z-0797-2020
Teleflex Medical · initiated February 27, 2019
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Codes / lots: GTIN 24026704549843 Lot Numbers: 74A1800577, 74G1802121, 74A1801939, 74H1700894, 74B1800363, 74J1700864, 74B1801604, 74J1702489, 74B1802746, 74C1801178, 74K1702257, 74L1700074, 74C1801294 , 74L1701701, 74C1802132, 74M1700121, 74G1800047, 74M1701150, 74G1800891, 74M1701769, 74G1801166
Reason for recall
The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.
FDA-determined cause: Under Investigation by firm
Action taken
The firm initiated the recall by letter on 02/27/2019. The notice stated that the device label incorrectly identified the products as sterile. Although incorrectly labeled as sterile, there is no requirement for sterility for its use. The firm requested that the distributors notify their customers. The firm did not request the return of the units, only to attach the notice to any recalled product in stock.
Details
- Recall number
- Z-0797-2020
- Initiated
- February 27, 2019
- Terminated
- September 6, 2023
- Product code
- NNY – Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
- Quantity
- 13104 devices
- Distribution
- ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
- Recalling firm
- Teleflex Medical, Morrisville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0796-2020 Class III | Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500The device label incorrectly states that the device is sterile. This product is an externally applied male… | 02/27/2019Terminated |