| Date Initiated by Firm | March 22, 2022 |
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| Create Date | May 20, 2022 |
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| Recall Status1 |
Terminated 3 on January 29, 2024 |
| Recall Number | Z-1119-2022 |
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| Recall Event ID |
90050 |
| 510(K)Number | K984187 |
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| Product Classification |
Gauze/sponge, internal - Product Code EFQ
|
| Product | Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm
Model Number: ENC4100 |
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| Code Information |
Lot Number: 202108 |
| FEI Number |
1527821
|
Recalling Firm/
Manufacturer |
Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
|
| For Additional Information Contact | SAME
440-392-7601 |
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Manufacturer Reason
for Recall | Product not approved for release for US distribution |
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FDA Determined
Cause 2 | Other |
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| Action | Crosstex notified accounts by Urgent Medical Device Recall letter dated 3/22/22 via email. Letter states reason for recall, health risk and action to take:
1. Please immediately inspect on-hand inventory for Ultra Pure Non-Woven Sponges, lot #202108 (part numbers ENC100 and ENC4100).
2. Please reply via email or complete the Recall Response Form included with this Notification Letter and return to cvalderrama@hu-friedy.com. Crosstex will provide instructions for returning the affected product to us.
3. Identify and notify all Customers who you have further distributed the affected product. Impacted Customers shall be provided with a copy of this letter and Recall Response Form.
4. Your Customer s Recall Response Forms shall be collected and reconciled to your distribution records to ensure all affected product is accounted for.
5. Crosstex will coordinate return of the product and credit issuance upon receipt of the completed Recall Response Form.
If you have questions regarding this matter, please contact me at 312-579-9258. |
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| Quantity in Commerce | 152 cases |
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| Distribution | Nationwide |
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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 = EFQ
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