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
FDA Recall Z-1119-2022 · Posted None
Advertisement
Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeEFQ
Date Initiated2022-03-22
Date Terminated2024-01-29
Product Quantity152 cases
Reason for Recall
Product not approved for release for US distribution
Firm 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 [email protected]. 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.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement