Manometer Tray, Jamshidi Needle Biopsy, Illinois (TJ) Needle Aspiration, Jamshidi (TJ) Needle Bone Marrow, Thoracentesis/Paracentesis Kit
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- Samson Sparks
- 6 years ago
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1 URGENT FIELD SAFETY NOTICE Affected product: MANOMETER TRAY JAMSHIDI NEEDLE BIOPSY ILLINOIS (TJ) NEEDLE ASPIRATION JAMSHIDI (TJ) NEEDLE BONE MARROW THORACENTESIS/PARACENTESIS KIT FSCA reference number: ISRC Type of Action: Product Removal March 9, 2017 Dear Business Partner: CareFusion a subsidiary of BD is voluntarily performing a Medical Device Recall to remove affected devices subject to the below described potential risk. DETAILS ON THE AFFECTED DEVICES: Manometer Tray, Jamshidi Needle Biopsy, Illinois (TJ) Needle Aspiration, Jamshidi (TJ) Needle Bone Marrow, Thoracentesis/Paracentesis Kit This recall applies to the following: Attachment A - Affected Product Lot Code List Attachment B - Graphics on where to locate the Product Code; Lot Code DESCRIPTION OF THE PROBLEM: CareFusion a subsidiary of BD has identified a potential risk associated with the packaging integrity - open seal of the affected products. If this failure is not recognized prior to a procedure it has the potential to result in an inflammatory / infectious response locally and/or systemically. Six (6) customer complaints have been received to date in the time frame of 01- NOV-2014 to 31-DEC-2016 with the issue of sterile packaging integrity. In all 6 reports the failure was recognized on visual inspection prior to patient use. No cases have been reported of patient(s) experiencing a serious injury or illness.
2 ACTION TO BE TAKEN BY THE CUSTOMER / USER: Check your inventory for the affected devices and place them in quarantine Complete the Customer Response Form certifying that all affected product in your inventory has been placed in quarantine and mail/ a copy of the response form to: CareFusion France 309 S.A.S 8 bis rue de la Renaissance Châteaubriant France Beatrice.Lambert@bd.com Please promptly return the enclosed Customer Response Form to expedite the correction process and acknowledge receipt of this notification. Transmission of this Field Safety Notice This notice needs to be passed on all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred. Please transfer this notice to other organisations on which this action has an impact. ACTIONS TO BE TAKEN BY CareFusion a subsidiary of BD: At receipt of your customer response form, Carefusion will inform you about further action to be taken of your quarantined products and a credit will be applied to your account for the affected product after certification and documentation of the required actions. We appreciate your prompt return of the enclosed Customer Response Form to expedite the correction process and acknowledge receipt of this Notification. This Field Safety Notice has been notified to the appropriate Regulatory Agency.
3 We recognize the inconvenience this issue may cause your facility and thank you for your support in this important matter. Sincerely, Enclosure(s): Customer Response Form Affected Product Code List (Attachment A ) Graphics on where to locate the Product Code; Lot Code (Attachment B )
4 URGENT FIELD SAFETY NOTICE CUSTOMER RESPONSE FORM Acknowledgment and Verification Form Product Reference: 4330; SN1015X; SN1016X; SN1017X; SN7016X; TIN3015; TIN3018; TJC3513; TJC4008; TJC4011; TJC6008; TJC6011; TJM3513: TJM4008;TJM4011; TJM6008; TJM6011; TPK1001 Refer to attachment A for Product - Lot Code list FSCA #: ISRC Name of Hospital / Facility Distributor Hospital / Facility Distributor Address Name Telephone number address Signature Date I have read and understand the contents of this Field Safety Notice and confirm that our inventory has been checked, and we no longer have the affected product in our inventory I have read and understood the contents of this Field Safety Notice and confirm that our medical equipment inventory has been checked, and we have the following affected product in our inventory
5 Model Number Lot Number QTY Note: If more space is needed for the above table please attach a separate document. Wholesaler/Distributor only: I have identified and notified all customers that purchased any affected product. Check below which method of notification was used (Include date and method): Date of Notification: Mail ; ; Fax ; Phone
6 The following person shall be contacted to coordinate the action (please complete if different than above) Name Telephone Number Please return a copy of the Customer Response Form to: CareFusion France 309 S.A.S 8 bis rue de la Renaissance Châteaubriant France Beatrice.Lambert@bd.com Once the form has been returned to CFN we will be contacting you regarding the disposition on any affected products.
7 URGENT Field Safety Notice AFFECTED PRODUCT / LOT CODES ATTACHMENT A Product Code Lot Code Product Description MANOMETER TRAY STERILE 10/BX MANOMETER TRAY STERILE 10/BX MANOMETER TRAY STERILE 10/BX MANOMETER TRAY STERILE 10/BX MANOMETER TRAY STERILE 10/BX MANOMETER TRAY STERILE 10/BX SN1015X JAMSHIDI NEEDLE BIOPSY 15G X 100MM DISP SN1016X JAMSHIDI NEEDLE BIOPSY 16G X 100MM DISP SN1017X JAMSHIDI NEEDLE BIOPSY 17G X 100MM DISP SN7016X JAMSHIDI NEEDLE BIOPSY 16G X 70MM DISP TIN ILLINOIS (TJ) NEEDLE ASPIRATION
8 Product Code Lot Code Product Description TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION TIN ILLINOIS (TJ) NEEDLE ASPIRATION 18GA TIN ILLINOIS (TJ) NEEDLE ASPIRATION 18GA TIN ILLINOIS (TJ) NEEDLE ASPIRATION 18GA
9 Product Code Lot Code Product Description TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 13GX3.5 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 13GX3.5 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 13GX3.5 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X4 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X4 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X4 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X4 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X4 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4
10 Product Code Lot Code Product Description TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X6 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X6 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X6 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X6 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 8G X6 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X6 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X6 TJC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X6 TJM JAMSHIDI (TJ) NEEDLE BM 13G TJM JAMSHIDI (TJ) NEEDLE BM 13G TJM JAMSHIDI (TJ) NEEDLE BM 13G TJM JAMSHIDI (TJ) NEEDLE BM 13G TJM JAMSHIDI (TJ) NEEDLE BM 13G TJM JAMSHIDI (TJ) NEEDLE BM 8G X 4
11 Product Code Lot Code Product Description TJM JAMSHIDI (TJ) NEEDLE BM 8G X 4 TJM JAMSHIDI (TJ) NEEDLE BM 8G X 4 TJM JAMSHIDI (TJ) NEEDLE BM 8G X 4 TJM JAMSHIDI (TJ) NEEDLE BM 8G X 4 TJM JAMSHIDI (TJ) NEEDLE BM 8G X 4 TJM JAMSHIDI (TJ) NEEDLE BM 11G TJM JAMSHIDI (TJ) NEEDLE BM 11G TJM JAMSHIDI (TJ) NEEDLE BM 11G TJM JAMSHIDI (TJ) NEEDLE BM 11G TJM JAMSHIDI (TJ) NEEDLE BM 11G TJM JAMSHIDI (TJ) NEEDLE BM 11G TJM JAMSHIDI (TJ) NEEDLE BM 11G TJM JAMSHIDI (TJ) NEEDLE BM 11G TJM JAMSHIDI (TJ) NEEDLE BM 11G
12 Product Code Lot Code Product Description TJM JAMSHIDI (TJ) NEEDLE BM 11G TJM JAMSHIDI (TJ) NEEDLE BM 8G X 6 TJM JAMSHIDI (TJ) NEEDLE BM 8G X 6 TJM JAMSHIDI (TJ) NEEDLE BM 11G X6 TJM JAMSHIDI (TJ) NEEDLE BM 11G X6 TJM JAMSHIDI (TJ) NEEDLE BM 11G X6 TPK THORACENTESIS/PARACENTESIS KIT 10/CS TPK THORACENTESIS/PARACENTESIS KIT 10/CS TPK THORACENTESIS/PARACENTESIS KIT 10/CS TPK THORACENTESIS/PARACENTESIS KIT 10/CS
13 URGENT: Medical Device Recall PACKAGING INTEGRITY OPEN SEAL Graphics on where to locate the Product Code / Lot Code ATTACHMENT B
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