—#193241

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

FDA product code: EFQ — Gauze/Sponge, Internal
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K984187
Affected lot / code info: Lot Number: 202108

Why it was recalled

Product not approved for release for US distribution

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2022-03-22
Terminated: 2024-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193241. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.