—#172371

Product

Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

FDA product code: PYC — Paracentesis Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number NS7726043

Why it was recalled

Affected products may have been manufactured with the catheter distal end hole too small

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA

Timeline

Recall initiated: 2019-04-09
Terminated: 2020-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172371. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.