Recall archive / FDA company announcement
Cook Medical: Transseptal Needle and Transseptal Needle Catheter — FDA announcement Oct 19, 2021
Reported terminated
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Oct 19, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Transseptal Needle and Transseptal Needle Catheter
- Reason
- Complaints of rust on the products
- Classification
- Not supplied
- Recalling firm
- Cook Medical
- Quantity
- Not supplied
- Agency-reported status
- Terminated in FDA listing
- Source record identifier
- b266f516639de15f
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | PRODUCT BRAND NAME | INTENDED USE | REFERENCE PART NUMBER (RPN) | ORDER NUMBER (GPN) | LOT NUMBER / UDI | RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS; Transseptal Needle | Intended for transseptal left heart access in both diagnostic and interventional procedures | TSNC-18-71.0 | G02364 | All | October 02, 2016 through July 22, 2021; TSNC-19-56.0 | G02365; Transseptal Needle with Catheter | Intended to facilitate transseptal entry into the left atrium | TSN-17-75.0-ENDRYS | G19261 |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| PRODUCT BRAND NAME | INTENDED USE | REFERENCE PART NUMBER (RPN) | ORDER NUMBER (GPN) | LOT NUMBER / UDI | RANGE OF MANUFACTURE DATES FOR AFFECTED PRODUCTS |
|---|---|---|---|---|---|
| Transseptal Needle | Intended for transseptal left heart access in both diagnostic and interventional procedures | TSNC-18-71.0 | G02364 | All | October 02, 2016 through July 22, 2021 |
| TSNC-19-56.0 | G02365 | ||||
| Transseptal Needle with Catheter | Intended to facilitate transseptal entry into the left atrium | TSN-17-75.0-ENDRYS | G19261 |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Oct 19, 2021
- Company announcement date
- Oct 18, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.