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Class 2 Device Recall Face Tent with 15 mm Adapter |
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Date Initiated by Firm |
January 24, 2011 |
Date Posted |
April 06, 2011 |
Recall Status1 |
Terminated 3 on August 14, 2012 |
Recall Number |
Z-1887-2011 |
Recall Event ID |
57972 |
Product Classification |
Oxygen Mask - Product Code BYG
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Product |
Face Tent with 15 mm Adapter, REF MD126, Manufacturer: King Systems Nobleville, IN.
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. |
Code Information |
IMKV8, IMNJ2, IMQX3, IMSR0, IMU97, IMXX0, IN1H1, IN3A2, IN6Z6, INAA6, INEE0, INF59, INGU4, INHT1, INJ16, INJE6, INK63, INL04, INLT4, INMV2, INPN6, INQF6, INRF2, INSP0, INRY6, INV51, INUU4, INVN4, INX39, INY27, IP0P6, IP332, IP208, IP4N1, IP5T2, IP7D7, IPAM0, IPBQ2, IPCZ7, IPE42, IPER6, IPGS5, IPIG9, IPKY4, IPLV3, IPML1, IPNS8, IPR26, IPU82, IPVM0, IPXC3, IPZ51, IQ024, IQ1E2, IQ271, IQ336, IQ3W0, IQ4Z9, IQ6Q5, IQAL8, IQCR8, IQDL1, IQIS8, IQLU4, IQMU0, IQQD4, IQSS6, IQWZ8, IR1G6, IR6J0, IR478, IRAF6, IRBP4, IRCG4, IRFT7, IRJS0, IRHK1, IRML5, IRPF5, IRU08, IRQF9, IRT66, IRSN2, IS092, IRXQ7, IS3H4, IS594, IS752, ISBS0, IS9N1, ISG89, ISHR7, ISL99, ISTV2, ISRV6, ISXQ0, IT186, IT3P1, ITAE7, IT727, ITAE8, ITBU2, ITFH4, ITI28, ITLC4, ITN42, ITPJ9, ITUQ8, ITXK1, IU4S4, IU3K4, ITZJ7, IU8B3, IUFH9, IUI17, IUKN7, IUN60, IUQL4, IUTA9, IUVY5, IUY74, IUZT5, IV1V5, IV432, IV6A3, IV887, IV7G0, IV9P8, IVCZ0, IPCF2, IQ3Y0, IQ698, IQPU1, IQUZ0, IR2I7, IRFY3, ISEX6, ISJN6 and IT3Q0. |
Recalling Firm/ Manufacturer |
King Systems Corp. 15011 Herriman Blvd Noblesville IN 46060
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For Additional Information Contact |
317-776-6823
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Manufacturer Reason for Recall |
The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. The sticky substance could result in inconvenience or in some remote cases cause patient harm.
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FDA Determined Cause 2 |
Other |
Action |
The firm issued an URGENT PRODUCT RECALL letter dated 1/24/2011. The letter identified the affected product and stated the reason for recall. The letter instructed consignees to cease all sales, to immediately examine their inventory, and to quarantine the product. The letter included a response form that is to be completed and returned. Distributors were instructed to inform their customers of the recall. King Systems Customer Service Department should be contacted at 1-800-642-5464 in order to receive a Return Authorization Number. The letter stated that consignees should return the recalled products to King Systems and the firm will replace the products or provide an acceptable substitute. Customers should contact Customer Service if they have any questions regarding the recall and the letter. |
Quantity in Commerce |
1198 cases of 50 per case 59,900 |
Distribution |
Nationwide Distribution -- NM, GA, TX, FL, IL, VA and LA. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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