Applied Medical Recalls Bard Embolectomy Catheters Due to Tip Separation
Applied Medical Resources Corp is recalling Bard Embolectomy Catheters because the tips may separate during use, posing a risk of dislodgement in patients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Applied Medical Resources Corp is recalling 28,799 Bard Embolectomy Catheters and 1 ml syringes. The recall involves specific models (CE0340DR, CE0380DR, CE0440DR, CE0480DR, CE0540DR, CE0580DR, and CE0680DR) distributed worldwide, including in the United States, Australia, Canada, and various European and Asian countries.
The firm initiated the recall after receiving reports of tip separation during usage. This defect may expose patients to the unintended dislodgement of the catheter tip from the body of the device. The agency has classified this as a Class I recall.
Healthcare providers and facilities should stop using the affected catheters and contact Applied Medical Resources Corp for further instructions on the recall process.
The recalled product
- Product
- Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X…
- Manufacturer
- Applied Medical Resources Corp
- Category
- Medical Device — Catheter
- Affected units
- 28,799
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 (20)
- Model CE0340DR
- BARD CATHETER
- lot numbers 1276248
- 1283930
- 1284935
- 1286527
- 1295731
- 1317372
- 1326198 Model CE0380DR
- lot numbers 1253338
- 1260036
- 1263505
- 1268151
- 1276218
- 1283938
- 1289018
- 1299712
- 1301797
- 1308727
- 1312145
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Applied Medical Resources Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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