Z-2440-2021Class II

COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers...

Name: Z-2440-2021 COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers...
Creator: Copan Italia
Published: 2021-07-09
License: https://open.fda.gov/license/

Copan Italia / initiated 2021-07-09 / Terminated / root cause: supplier

FDA source

Copan Italia began a recall of COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp... on 2021-07-09. FDA classified it as Class II and gives the reason as "A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2440-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-09
Posted: 2021-09-09
Terminated: 2024-01-25
Recalling firm: Copan Italia
Product: COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20; REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm; REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm; REF: 220252, P/N 503CS01.BD, Flexible, Sterile Single Wrapped Molded bp 100 mm; REF: 503CS01/503CS01.BX, Flexible, Sterile Single Wrapped, Molded bp 100mm REF: 50U004DS, hDNA Free, Regular sterile in dry tube Molded Break Point 20 mm; REF: 50U009DS02, hDNA Free, Regular, Sterile, 2pcs Packed; REF: 518CS01, Minitip, Ster. Single Wrapped, Molded bp 100mm; REF: 220251, P/N: 518CS01.BD, Minitip, sterile Single Wrapped Molded bp 100mm; REF: 519C/519C.BX, Regular Sterile, Molded break point 100 mm; REF: 220250 P/N: 519CS01.BD, Regular, Sterile Single wrapped Molded bp 100mm; REF: 525CS01, Ultra-Thin Minitip, sterile single wrapped, molded bp 80 mm; REF: 528C, Large Tip Swab, Handle with Stopper, in dry tube REF: 534CS01, Flexible Nylon, Sterile Single Wrapped; REF: 551C, Minitip Sterile in dry tube, Molded Break Point 80 mm; REF: 552C/552C.BX, Regular sterile in dry tube Molded Break Point 80 mm; REF: 553C, Flexible sterile in dry tube, molded bp 100 mm; REF: 553C.LC, Flexible Sterile in dry tube, molded bp 100 mm; REF: 5U002S, Regular, sterile, in tube, 80 mm breakpoint, with low stopper; 5U048N01.BIO, REF: 5U055S02.HG, Regular FLOQSwabs with 20mm breakpoint 100 peelpouches, 2 swabs per peelpouch; REF: 5U056S.IUO, FLOQSwats ADULT IN DRY TUBE, Investigational Use Only; REF: 5UO57S.IUO, FLOQSwabs CHILD IN DRY TUBE, Investigational Use Only
Product code: KXG Applicator, Absorbent Tipped, Sterile
Reason for recall: A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: On July 26, 2021, Copan Italia issued a "Urgent: Medical Device Recall" notification to all affected consignee. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. This notice should be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 2. Please identify, segregate, and discontinue use of all affected product included within ATTACHMENT #1_FLOQSwabs Recall product list . 3. Confirm you have read and understood the recall instructions provided in the letter in writing using the FORM #1_FLOQSwabs Recall Return Response , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murrieta, CA US 92562, Phone: 800 216 4016 Ext. 204, [email protected] 4. Disposal must be performed according to local regulation and it does not require biohazard disposal precautions. Evidence or declaration of Product disposal must be returned in writing, using the FORM #2_FLOQSwabs Recall Disposal evidence , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murrieta, CA US 92562, Phone: 800 216 4016 Ext. 204, [email protected] 5.If you are not in the position to identify, segregate or discard the Product you must advise in writing using the FORM #1_FLOQSwabs Recall Return Response , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murrieta, CA US 92562, Phone: 800 216 4016 Ext. 204, [email protected] 6.This recall should be carried out to the end user level for all the affected Products that have been distributed including any products under private labeling, incorporated or utilized as kit components. 7. Any adverse events associated with recalled Product must be communicated in writing using the FORM #1_FLOQSwabs Recall Return Response , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murri
Quantity in commerce: 3,029,400 units
Distribution: US nationwide distribution, including Puerto Rico.
Product codes and lots: Mode Number: Lot number: 501CS01: 1816581 and 2027890; 501CS01.Q100: PJ10453, PJ10636 and PJ10667; 501CS01.Q20: J10407; 502CS01: 1816964, 2027239, 2027877; 503CS01: 1807589, 1809095, 1814761, 1814762, 1814763, 1816968, 1821362, 2025887; 503CS01.BD: 2031801; 503CS01.BX: 50U004DS and 1818685; 50U009DS02: 1825274; 518CS01: 2008058 and 2027915; 518CS01.BD: 2008058; 519C: 1816921; 519C.BX: 1811060 and 1816921; 519CS01.BD: 2027871; 525CS01: 2009380; 528C: 1808601, 534CS01, 1707256; 551C: 1813221; 552C: 1819144; 552C.BX: 1819144; 553C: 1810293, 1816440, 1817638, 2004854: 553C.LC: 1811976, 1814054, 1814717, 1817637, 1820999; 5U002S: 1812705; 5U048N01.BIO: 1810727 and 1818912; 5U055S02.HG: 1814413; 5U056S.IUO: 1816448; 5U057S.IUO: 1816451

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2440-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2440-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-15	2021-09-09

Product code KXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)