Chiba Biopsy Needles Recalled for Potential Sterility Compromise
Cook Incorporated is recalling Chiba Biopsy Needles due to packaging that may have low seal strength, potentially compromising device sterility. The recall affects 6,178 units distributed worldwide.
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: This is an FDA Class II recall of a medical device used for invasive procedures. The packaging defect directly compromises device sterility, creating a risk of infection for patients undergoing biopsy procedures. However, no illnesses or injuries have been reported in the source material.
Plain-English summary
Cook Incorporated is recalling Chiba Biopsy Needles, used for aspiration biopsy procedures, due to a packaging defect. The packaging on affected units may have low seal strength and not meet peel strength specifications, which could compromise the sterility of the device.
Affected products include nine part numbers of the Chiba Biopsy Needle with specific reference part numbers and order numbers. A total of 6,178 units were affected by this recall.
The affected devices were distributed worldwide, including nationwide distribution in the United States and distribution to Austria, Australia, Brazil, Canada, Switzerland, Germany, Spain, Great Britain, Hong Kong, Ireland, Israel, India, Italy, New Zealand, and Singapore. Specific lot numbers and UDI codes for all affected part numbers have been identified.
Patients and healthcare providers who have these devices should not use them if they have not yet been used. Contact Cook Incorporated or the healthcare facility if you have questions about whether you have been affected by this recall.
The recalled product
- Product
- Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314…
- Manufacturer
- Cook Incorporated
- Hazard
- Affected units
- 6,178
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)
- RPN/UDI/Lot Numbers 1) DCHN-18-10.0 (01)00827002015593(17) 15787141
- 15787142
- 15787693
- 15794668
- 15794669
- 15794728
- 15797998 2) DCHN-18-10.0-U (01)00827002050402(17) NS15781793
- NS15781794
- NS15783895 NS15783896
- NS15783899
- NS15783900
- NS15784336
- NS1580853
- 5 NS15808536
- 15785990
- 15791249 15794719 7) DCHN-22-15.0-U (01)00827002033146(17)15784638
- 15784722
- 15784724
- 15795935
- 15797991
Distribution
Part of a larger recall action
This product is one of 8 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.
See all 8 products in this recall →Related recalls
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