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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 & string see related information
Date Initiated by Firm September 03, 2015
Create Date December 17, 2015
Recall Status1 Terminated 3 on May 02, 2016
Recall Number Z-0435-2016
Recall Event ID 72276
Product Classification Applicator, ent drug - Product Code LRD
Product AbsorbENT, 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
Recalling Firm/
Manufacturer		 Summit Medical, Inc.
815 Northwest Pkwy Ste 100
Eagan MN 55121-1658
For Additional Information Contact Nicole 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
Action Consignees 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 Commerce 9 boxes (10 /box)
Distribution Distributed to CA.
Total Product Life Cycle TPLC 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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