| Date Initiated by Firm | June 15, 2017 |
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| Create Date | February 27, 2018 |
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| Recall Status1 |
Terminated 3 on July 17, 2018 |
| Recall Number | Z-0751-2018 |
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| Recall Event ID |
79100 |
| 510(K)Number | K153540 |
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| Product Classification |
Wrap, sterilization - Product Code FRG
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| Product | Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case
Product Usage:
The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use. |
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| Code Information |
Model# 883116 Lot# 161118A |
Recalling Firm/
Manufacturer |
Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
|
| For Additional Information Contact | Mrs. Lindsay Gaffga
440-392-7521 |
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Manufacturer Reason
for Recall | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch. |
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FDA Determined
Cause 2 | Component change control |
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| Action | Steris sent an Urgent Voluntary Recall Notice letter dated July 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately inspect on-hand inventory for recalled product. If you have product in your possession, please quarantine it and contact firm to coordinate shipment of replacement product. If you have questions regarding this matter, please contact STERIS Customer Service at 1-800-548-4873. |
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| Quantity in Commerce | 5 |
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| Distribution | US Nationwide Distribution |
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| 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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| 510(K) Database | 510(K)s with Product Code = FRG
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