Intelligent Delivery System, Straight, product code iDriveS; Intelligent Delivery System, Curved, product code iDriveC; Intelligent Delivery System, Flexible, product code iDriveF.
This recall has been terminated (originally issued November 23, 2009).
- Company
- Surgical Devices/Covidien
- Recall Initiated
- September 23, 2009
- Posted
- November 23, 2009
- Terminated
- March 8, 2010
- Recall Number
- Z-0406-2010
- Quantity
- 360 units
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.
Distribution
The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece.
Lot / Code Info
all codes
Root Cause
Nonconforming Material/Component
Action Taken
The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.