Straight extension catheter trays recalled over header bag seal integrity
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 24 cm, over header bag seal integrity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a compromised sterile barrier on a catheter tray creates an infection risk, and no injuries are reported.
Plain-English summary
The MAHURKAR Acute High Pressure Triple Lumen Catheter Tray with straight extensions and IC safety components, 12 Fr/Ch (4.0 mm) x 24 cm, REF 8888104004HP, from Mozarc Medical US, is being recalled.
The recall follows a potential issue with the seal integrity of the header bag packaging.
The recall covers 3,258 units carrying unit UDI-DI 10884521832817 and carton UDI-DI 20884521128061. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The header bag maintains the sterile barrier around the tray, so a seal problem can compromise sterility. Facilities holding affected lots should quarantine them and follow the firm's instructions.
The recalled product
- Product
- MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
- Manufacturer
- Mozarc Medical US LLC
- Category
- Medical Device — Catheter
- Hazard
- seal-failure
- sterility-breach
- infection-risk
- packaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- REF Number: 8888104004HP
- UDI-DI: (Individual unit) 10884521832817
- (Carton) 20884521128061
- Lot number: 2427800166
Distribution
Distributed nationwide across the United States.
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