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Page 1 of 2 Urgent Medical Device Recall Notification LMA® MAD Nasal™ Intranasal Mucosal Atomization Device October 27, 2016 To: Customer of Teleflex Medical Products Teleflex Medical Incorporated (“Teleflex Medical”) has issued a recall for the following product codes and lot numbers: Product Code Batch/ Lot# Product Code Batch/ Lot# Product Code Batch/ Lot# MAD100 160105 MAD130OS 160436 MAD300 160409 160137 160803 160422 160302 MAD140 160125 160432 160321 160218 160440 160402 160437 160500 160435 160610 160518 160506 160801 160602 160523 MAD140OS 160226 160611 160609 160438 160621 160620 160727 160631 160707 MAD300 160108 160701 160802 160117 160708 160813 160126 160718 MAD100OS 160322 160145 160728 160524 160146 160800 160630 160200 160804 MAD110 160217 160219 160814 160507 160225 160816 MAD110OS 160240 160231 160823 160312 160300 MAD300B 160410 MAD130 160107 160313 160138 160327 160517 160400 Teleflex Medical is recalling these products as they may not deliver a fully atomized plume of medication. Teleflex Medical has received complaints that the affected lots produced a straight stream instead of an atomized spray. The failure of the device to deliver an atomized plume may impair the effectiveness of the medication with which it is used. This can lead to serious injury or death in certain emergency situations, such as where the device is used in an off-label manner for needle-free delivery of drugs for reversal of life threatening narcotic overdose, reversal of life threatening hypoglycemia, or treatment of epileptic seizures. ---PAGE BREAK--- Page 2 of 2 Our records indicate that you have received products that are subject to this recall. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-[PHONE REDACTED], Attn: Customer Service or email to [EMAIL REDACTED]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855- 419-8507, Attn: Customer Service or email to [EMAIL REDACTED]. This will allow us to document your receipt of this letter. The U.S. Food and Drug Administration has been notified of this action. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-[PHONE REDACTED]. For and on behalf of Teleflex Medical, Karen Boylan Karen Boylan VP, Global RA/QA Enclosure