ENDO Pharmaceuticals Solutions, Inc. 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

No expiration dates printed on the packaging

Recommended Action

Per FDA guidance

Endo Pharmaceuticals issued Medical Device Market Withdrawal letter dated 12/8/22 to Distributor and End-Users via email/mail. Letter states reason for recall, health risk and action to take: 1. If you have any affected lots in your inventory, please immediately quarantine to prevent any further use. 2. Please complete the Market Withdrawal Acknowledgement and Receipt Form (attached below)and email to marketwithdrawal@endo.com or return by fax to 1-610-561-3085. 3. A shipping label will be mailed to the address provided on the Market Withdrawal Acknowledgement and Receipt form and any affected devices along with the completed form are returned to: Endo Pharmaceuticals 8 Clarke Dr., Suite 6 Cranbury, NJ 08512 Attn: Trocar Market Withdrawal Returned product will be replaced by Endo Pharmaceuticals Inc. Customers who have questions or need additional information regarding this correction may contact Endo at 1-800-462-3636. If you have further distributed this product, please identify and notify your customers of this product recall. Please ensure that this notification is forwarded to all Healthcare Professionals who have received the 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants from the lots identified in Table 1 (page 3 of 5). Please let end users know to return for replacement . November 8, 2022 Endo notified the wholesaler to prevent any further distribution of the affected lots.