FDA Medical Device Recalls (openFDA)
Cook Inc.: Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
- Recall number
- Z-1722-2019
- Recalling firm
- Cook Inc.
- Product
- Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
- Status
- Terminated
- Initiated
- 2019-04-09
- Posted
- not on file
- Terminated
- 2020-04-28
- Reason
- Affected products may have been manufactured with the catheter distal end hole too small
- Root cause
- not on file
- Action
- On April 9, 2019 Cook Medical issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Customers were advised to take the following Actions: 1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited. 3. Complete and return the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or by email to FieldActionsNA@CookMedical.com. 4. The notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com.
- Quantity
- 83 kits
- Distribution
- Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA
- Lot, serial or model codes
- Lot Numbers 7716007 7703324 NS7703501 NS7703502 NS7703503 NS7704718 NS7704722 NS7704727 NS7704728
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PYC
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28