Urgent Medical Device Recall Rad by fjzhxb

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									«Hospital_Name» «Users_Name» - «Department» «Customer_Address» «Zip_Code» «City» - «Country name»

Reference: FCA 2007-22

September/October xx, 2007

Urgent Medical Device Recall Radial Jaw® 4 large Capacity Biopsy Forceps
Dear «Users_Name», Boston Scientific is initiating a voluntary recall of specific lots/batches of Radial Jaw® 4 Large Capacity Biopsy Forceps. These devices present no safety hazard to the patient and still acquire tissue samples as intended. We have discovered that a batch of jaw components did not complete a required manufacturing finishing process. These jaw components were included in the manufacture of fourteen lost/batches of Radial Jaw® 4 Large Capacity Biopsy Forceps. Boston Scientific is recalling these lots/batches because they did not complete all required manufacturing processes. Our records indicate that your facility received some of the affected product. The table below provides a complete list of all recalled products, including Product Description, Material Number, Catalog Numbers and Lot/Batch Numbers. Please note that only the material and batch number listed below are affected. No other Boston Scientific product is involved in this voluntary recall.
Product Description Radial Jaw® 4 Large Capacity w/Needle 240cm (box20) Radial Jaw® 4 Large Capacity w/Needle 240cm (box40) Material Number (UPN) - Outer box M00513331 M0051332 Material Number (UPN) – Inner Pouch M00513330 M0051330 Catalog number 1333 1333 Lot/Batch Number
(Outer box & Inner Pouch)

Radial Jaw® 4 Large Capacity 240cm (box20)

M00513321

M00513320

1332

8984691, 9005322, 9005726, 9005727 8984687, 8984688, 8984689, 8990186, 9003394, 9003396, 9005718, 9005719, 9017283 8990184

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INSTRUCTIONS: 1. Please immediately discontinue use of all the Boston Scientific product batches listed above and remove all of the affected units from your inventory (whether in Cath Lab., Radiology, Fluoroscopy Suite, Interventional Operating Room, Central Supply, Shipping & Receiving and any other relevant location). Segregate the units in a secure place, pending return to Boston Scientific. 2. Please complete the attached Verification Form even if you do not have any product to return. 3. When completed, please fax the Verification Form to your local Boston Scientific Customer Service to the attention of «Customer_Service_Fax_Number» on or before xx October/November 2007. 4. If you have products to return, please package them in an appropriate shipping box and contact «Customer_Service_Tel» of your local Boston Scientific Customer Service, to arrange return. 5. Please pass this notice to any health professional of your organization that need to be aware and to any organization where the potentially affected devices have been transferred (If appropriate). Your Competent Authority is being notified of this voluntary recall. We regret any inconvenience that this action may cause, and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. If you have any questions or would like assistance with this Medical Device Recall, please contact your local Sales Representative. Yours sincerely,

Linda Geurten Quality Department. Boston Scientific International S.A

Attachment: - Verification Form

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