Cook Inc. Recalls Fixed Core Wire Guides Due to Manufacturing Defects
Cook Inc. is recalling 61 Fixed Core Wire Guides that may be bent or contain loose foreign matter due to being dropped during manufacturing.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Cook Inc. is recalling 61 units of the Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. This medical device is a curved wire guide with a PTFE coating made from stainless steel, used to assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
The recall was initiated because the affected product was dropped during manufacturing. This incident may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
The affected units are from Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931. These products were distributed in the United States to Arizona, Iowa, Indiana, Massachusetts, and North Dakota. The FDA has classified this recall as Class I.
The recalled product
- Product
- Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Vascular Access
- Affected units
- 61
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 (1)
- Lot 13199931 with UDI (01)00827002005174(17)250824(10)13199931
Distribution
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