Transjugular access sets recalled over products manufactured out of specification
Cook Incorporated is recalling 15 Ring Transjugular Intrahepatic Access Sets because affected lots may have been cut to the incorrect length, not correctly trimmed, and not properly inspected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites out of specification manufacturing with no stated consequence or reported harm.
Plain-English summary
Ring Transjugular Intrahepatic Access Sets, reference part numbers RTPS-100 and RTPS-100-10.0, are being recalled by Cook Incorporated. The set is intended for transjugular liver access in diagnostic and interventional procedures.
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
The record lists 15 units, with order numbers, UDIs and lot numbers listed in the enforcement record including order number G06541 under UDI (01)00827002065413. Distribution was worldwide. The FDA has classified the action as Class II.
The record describes a manufacturing specification deviation and states no consequence or reported injuries. Facilities should quarantine affected lots and follow Cook's instructions.
The recalled product
- Product
- Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Access set
- Affected units
- 15
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 (6)
- 1) Reference Part Number RTPS-100: Order Number G06541
- UDI (01)00827002065413(17)280722(10)16705779
- Lot Number 16705779
- 2) Reference Part Number RTPS-100-10.0: Order Number G29769
- UDI (01)00827002297692(17)280624(10)16659044
- Lot Number 16659044
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Cook Incorporated 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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