Z-1119-2022Class II

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...

Name: Z-1119-2022 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...
Creator: Steris Corporation
Published: 2022-03-22
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2022-03-22 / Terminated

FDA source

Steris Corporation began a recall of 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 on 2022-03-22. FDA classified it as Class II and gives the reason as "Product not approved for release for US distribution". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1119-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-22
Posted: 2022-05-20
Terminated: 2024-01-29
Recalling firm: STERIS Corporation
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
Product code: EFQ Gauze/Sponge, Internal
Reason for recall: Product not approved for release for US distribution
FDA root cause: Other
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.
Quantity in commerce: 152 cases
Distribution: Nationwide
Product codes and lots: Lot Number: 202108

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1119-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1118-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-20
Z-1119-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-20

Product code EFQ

K984187UnclassifiedCrosstex Non-Woven SpongesCrosstex Intl. / cleared 1999-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)