Recall Z-1037-2019— ConvaTec, Inc

Name: FDA recall Z-1037-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-09

Class II · Ongoing

Class II FDA medical device recall by ConvaTec, Inc, initiated 2019-01-09. It names one FDA 510(k) clearance: K896729. Product: Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).. Reason: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier..

Recalling firm: ConvaTec, Inc
Classification: Class II
Status: Ongoing
Initiated: 2019-01-09
Firm location: Greensboro, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K896729 — NELATON-, FEMALE - OR TIEMANN CATHETERUnoplast A/S·cleared 1990-11-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).

Reason for recall

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.