Reported Apr 24, 2024 · Ongoing
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0…
Cook Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
9 of 9 products
| Model / number | Product as published |
|---|---|
DCHN-18-10.0 | NUMBER (GPN): 1) |
DCHN-18-10.0-U | 2) |
DCHN-18-15.0 | 3) |
DCHN-22-10.0 | 4) |
DCHN-22-10.0-U | 5) |
DCHN-22-15.0 | 6) |
DCHN-22-15.0-U | 7) |
DCHN-22-20.0 | 8) |
DCHN-22-20.0-U | 9) |
- Lot codes and dates
9 of 9 products
Products covered by this recall # Barcodes Product as published 1 00827002015593DCHN-18-10.0 (01)00827002015593(17) 15787141, 15787142, 15787693, 15794668, 15794669, 15794728, 15797998 2 00827002050402DCHN-18-10.0-U (01)00827002050402(17) NS15781793, NS15781794, NS15783895 NS15783896, NS15783899, NS15783900, NS15784336, NS1580853,5 NS15808536, NS15808537 3 00827002008502DCHN-18-15.0 (01)00827002008502(17) 15595244 4 00827002008526DCHN-22-10.0 (01)00827002008526(17) 15628472 5 00827002039780DCHN-22-10.0-U (01)00827002039780(17) 15614507 6 00827002000124DCHN-22-15.0 (01)00827002000124(17) 15628470, 15785990,15791249 15794719 7 00827002033146DCHN-22-15.0-U (01)00827002033146(17)15784638, 15784722,15784724, 15795935, 15797991, 15797992 8 00827002000131DCHN-22-20.0 (01)00827002000131(17) 15629865 9 00827002043381DCHN-22-20.0-U (01)00827002043381(17) NS15808547 - Amount recalled
- 6,178 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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