URGENT: MEDICAL DEVICE RECALL SECURE Compounder Bags. Customer Notification Letter

Transcription

1 URGENT: MEDICAL DEVICE RECALL SECURE Compounder Bags Customer Notification Letter July 7, 2106 Dear Sir/Madame: The purpose of this letter is to advise you that The Metrix Company is voluntarily recalling the Secure AutoComp6 High Speed Compounder. The compounders may not be able to maintain the fill accuracy requirements for the compounded bag as outlined in the user s manual. Therefore, the patient receiving the compounded bag may not receive the correct quantity of individual parenteral nutrition solutions or the correct overall quantity of parenteral nutrition solutions. No adverse events have been reported to The Metrix Company as a result of this issue. Our records indicate that you received one of the affected compounders since January 1, Medical Specialties Distributors LLC is asking all customers to follow the steps below: 1. Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Complete the Response form and return by fax to or scan to recall@msdistributors.com. 4. RECALLED PRODUCT LIST See attached serial number list of affected AutoComp6 Compounders. For any questions please contact: Regulatory Affairs This Urgent Voluntary recall is being made with the knowledge of the Food and Drug Administration (FDA). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Online at: For Regular Mail: use postage-paid, pre-

2 addressed FORM FDA 3500 available at Sincerely, Philip Russo Regulatory Affairs Supervisor Attachments: Recall Return Response Form

3 MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form SECURE Compounder Bags Response is Required Customer Response Form Facility Name: Contact Name: Facility Address: Phone: Fax: 1. I have read and understand the recall instructions provided in the Customer Response Letter dated. Yes No 2. I have checked my stock and have quarantined inventory consisting of Autocmp6 High Speed Compounder 3. I will contact Metrix for a Return Goods Authorization (RGA) by returning a copy of this form to Metrix using one of the methods listed below. form Recall.Coordinator@metrixco.com to: Fax form to Recall Coordinator at Mail form to Recall Coordinator The Metrix Company 4400 Chavenelle Road, Dubuque, IA 52002

4 4. I will return all items listed above to Metrix according to the instructions included with the RGA Form. 5. I have zero AutoComp6 High Speed Compounders for return Were there any adverse events associated with the recalled product? Yes No If yes, please explain: Return Response Box: Please provide any additional information if applicable. Questions: (when applicable) Please have Customer Service contact me. Signature of Receipt Date Printed Name/Title Using one of the following methods: PLEASE RETURN THIS COMPLETED FORM AS SOON AS POSSIBLE to Medical Specialties. 6. Return by fax to or scan to recall@msdistributors.com.

5 URGENT: MEDICAL DEVICE RECALL SECURE Compounder Bags Customer Notification Letter June 29, 2016 Dear Sir/Madame: The purpose of this letter is to advise you that The Metrix Company is voluntarily recalling the Secure Compounder Bags as listed below. The recall of these bags has been initiated because when used with the AutoComp6, AutoComp6 XP and AutoComp6 XPS High Speed Compounders, the compounders may not be able to maintain the fill accuracy requirements for the compounded bag as outlined in the user s manual. Therefore, the patient receiving the compounded bag may not receive the correct quantity of individual parenteral nutrition solutions or the correct overall quantity of parenteral nutrition solutions. No adverse events have been reported to The Metrix Company as a result of this issue. Our records indicate that you received one or more of the affected products since January 1, 2006; see the details in the table below. Medical Specialties Distributors LLC is asking all customers to follow the steps below: 1. Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Complete the Response form and return by fax to or scan to recall@msdistributors.com. 4. RECALLED PRODUCT LIST Metrix part Description LITER COMPOUNDER BAG BAG-AUTO ADMIN 4000ML EVA BAG-AUTO ADMIX 1000ML EVA COMPOUNDER BAG 3 LITER SECURE EVA COMPOUNDER BAG 2000ML EVA COMPOUNDER BAG 1000ML PVC 1000ML COMPOUNDER BAG EVA COMPOUNDER BAG 250ML EVA COMPOUNDER BAG 500ML AUTO ADMIX 500ML EVA AUTO ADMIX 2000ML EVA BAG-AUTO ADMIX 3000ML EVA EVA COMPOUNDING BAG 3000ML EVA COMPOUNDING BAG 4000ML W/DET EVA DUAL CHAMBER GRAVITY 2000ML SECURE EVA COMPOUNDER BAG 250ML

6 66015 SECURE EVA COMPOUNDING BAG 1000ML SECURE EVA COMPOUNDING BAG 1500ML SECURE EVA COMPOUNDING BAG 2000ML SECURE EVA COMPOUNDING BAG 3000ML SECURE EVA COMPOUNDING BAG 4000ML SECURE EVA COMPOUNDING BAG 500ML TPN 1500ML AUTOCOMP BAG For any questions please contact: Regulatory Affairs This Urgent Voluntary recall is being made with the knowledge of the Food and Drug Administration (FDA). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Online at: For Regular Mail: use postage-paid, pre-addressed FORM FDA 3500 available at Sincerely, Philip Russo Regulatory Affairs Supervisor Attachments: Recall Return Response Form

7 MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form SECURE Compounder Bags Response is Required Customer Response Form Facility Name: Contact Name: Facility Address: Phone: Fax: 1. I have read and understand the recall instructions provided in the Customer Response Letter dated. Yes No 2. I have checked my stock and have quarantined inventory consisting of: Metrix Part # Lot Number Quantity If additional items are in your inventory, please provide them as an attachment to this form.

8 3. I will contact Metrix for a Return Goods Authorization (RGA) by returning a copy of this form to Metrix using one of the methods listed below. form to: Recall.Coordinator@metrixco.com Fax form to Recall Coordinator at Mail form to Recall Coordinator The Metrix Company 4400 Chavenelle Road, Dubuque, IA I will return all items listed above to Metrix according to the instructions included with the RGA Form. Were there any adverse events associated with the recalled product? Yes No If yes, please explain: Return Response Box: Please provide any additional information if applicable. Questions: (when applicable) Please have Customer Service contact me. Signature of Receipt Date Printed Name/Title Using one of the following methods: PLEASE RETURN THIS COMPLETED FORM AS SOON AS POSSIBLE to Medical Specialties. 5. Return by fax to or scan to recall@msdistributors.com.