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U.S. Department of Health and Human Services

Class 2 Device Recall Doyle AbsorbENT Nasal Pack w/airway & string

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 Class 2 Device Recall Doyle AbsorbENT Nasal Pack w/airway & stringsee related information
Date Initiated by FirmSeptember 03, 2015
Create DateDecember 17, 2015
Recall Status1 Terminated 3 on May 02, 2016
Recall NumberZ-0435-2016
Recall Event ID 72276
Product Classification Applicator, ent drug - Product Code LRD
ProductAbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
Code Information 160889, 161354
FEI Number 3008719017
Recalling Firm/
Manufacturer		 Summit Medical, Inc.
815 Northwest Pkwy Ste 100
Eagan MN 55121-1658
For Additional Information ContactNicole Dove
651-789-3921
Manufacturer Reason
for Recall		Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does not have the split in the packing.
FDA Determined
Cause 2		Process control
ActionConsignees were sent a Summit Medical "Medical Device Recall" letter, dated September 2, 2015. The letter described the problem and the product involved in the recall. It also advised consignees to immediately examine their inventory, quarantine the product, and to complete the attached response form, as well as follow the instructions provided regarding the affected product. For questions, contact Nicole Dove at 651-789-3921 or ndove@summitmedicalusa.com.
Quantity in Commerce9 boxes (10 /box)
DistributionDistributed to CA.
Total Product Life CycleTPLC Device Report
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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