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U.S. Department of Health and Human Services

Class 2 Device Recall FLOQSwab

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  Class 2 Device Recall FLOQSwab see related information
Date Initiated by Firm July 09, 2021
Date Posted September 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-2440-2021
Recall Event ID 88437
Product Classification Applicator, absorbent tipped, sterile - Product Code KXG
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
Code Information 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
Recalling Firm/
Manufacturer
Copan Italia
Via Francesco Perotti 10
Brescia Italy
For Additional Information Contact Norman Sharples
800-2164016
Manufacturer 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.
FDA Determined
Cause 2
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, InfoRecall@copanusa.net 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, InfoRecall@copanusa.net 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, InfoRecall@copanusa.net 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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