Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration
Cook Inc. is recalling 554 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 involves a medical device with a defect that could lead to fluid leakage or air aspiration, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Cook Inc. is recalling 554 units of the Connecting Tube - Female to Male Luer Lock (model HPCT8.8-100-M-FM). The recall involves specific lots: NS7835000, NS7835001, NS7846433, NS7853877, NS7853880, NS7866660, NS7875342, NS7898129, NS7898130, NS7898131, NS7928009, NS7928014, and NS7940349.
The recall was initiated because the cap-adapter assembly of the device may potentially not be adequately tightened. This defect could possibly lead to fluid leakage from the connecting tube or air aspiration into the tube. The device is intended to serve as a conduit between a fluid reservoir and a vascular catheter in patients, often used during angiographic procedures.
The affected products were distributed to accounts in seven U.S. states: Alabama, California, Georgia, Nebraska, Nevada, New York, and Texas. International distribution occurred in Japan, Korea, and Taiwan. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect…
- Manufacturer
- Cook Inc.
- Affected units
- 554
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 (13)
- Lots NS7835000
- NS7835001
- NS7846433
- NS7853877
- NS7853880
- NS7866660
- NS7875342
- NS7898129
- NS7898130
- NS7898131
- NS7928009
- NS7928014
- NS7940349
Distribution
Part of a larger recall action
This product is one of 6 recalled by Cook 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.
See all 6 products in this recall →Related recalls
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