Bard PowerPort isp MRI Implantable Port Recall for Incorrect Catheter Barb Tip
Bard Peripheral Vascular Inc is recalling 824 PowerPort isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical delay) where no specific injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 824 units of PowerPort isp M.R.I. Implantable Ports with attachable or pre-attached 9.6 F open-ended single-lumen venous catheters. The recall involves specific reference numbers 1809660, 1809661, 1859660, and 1859661, associated with specific lot numbers and UDIs. The products were distributed worldwide, including nationwide in the United States and in countries such as Brazil, Canada, EMEA, Korea, Mexico, and New Zealand.
The firm identified that the products may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This manufacturing error can result in a prolongation of the surgical operation. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should contact Bard Peripheral Vascular Inc for further instructions regarding the return or replacement of these devices. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- 1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UDI: (01)00801741027154 2. PowerPort isp M.R.I. Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 824
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 (5)
- RECR0983
- RECR1885
- RECR2220
- RECS0030
- RECS2758 4. Lot # for 1859661 - RECS2974
Distribution
Part of a larger recall action
This product is one of 10 recalled by Bard Peripheral Vascular Inc 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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