A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use on
FDA device recall Z-1268-2013 · posted 2013-05-07 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
- Action taken
- Baxter sent an "Urgent Product Notification" dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taked. Customers are advised to locate and remove all of the affected products from their inventory. If the products were further distributed, consigneees are requested to notify their customers of the recall. Products can be returned for credit by contacting Baxter. An acknowledgement form is required to be compelted by customers.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 units
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
- Date initiated
- 2013-03-28
- Date posted
- 2013-05-07
- Date terminated
- 2017-07-31
- Location
- Deerfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RADIATION STERILIZED ADMIN. SET (K811078) | Travenol Laboratories, S.A. | 1981-07-02 |