Copan Floqswabs recall: Sterility Concern
COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped…
Why was Copan Floqswabs recalled?
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped…
- Recalling firm
- Copan Italia
- Quantity
- 3,029,400 units
- Distribution
- US nationwide distribution, including Puerto Rico.
- Recall date
- September 15, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)