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U.S. Department of Health and Human Services

Class 2 Device Recall BD BBL CultureSwab EZ Collection and Transport System (Part 220144)

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 Class 2 Device Recall BD BBL CultureSwab EZ Collection and Transport System (Part 220144)see related information
Date Initiated by FirmMay 02, 2025
Date PostedJune 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1937-2025
Recall Event ID 96807
510(K)NumberK993161 
Product Classification System, transport, aerobic - Product Code JTW
ProductBD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Code Information Lot: 2415377/UDI: 38053326002145
Recalling Firm/
Manufacturer		 Copan Italia
Via Francesco Perotti 10, 18
Brescia Italy
For Additional Information ContactLetizia Zagni
030-2687211
Manufacturer Reason
for Recall		Swabs for specimen collection may be prone to breakage during product usage.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn May 2, 2025, Copan Italia Spa issued a Urgent: Medical Device Recall" notification to affected consignees via E-Mail. Copan asked consignees to take the following steps: 1. Trace and dispose of all affected products 2. Disposal must be carried out according to local regulations. Evidence or declaration of Product disposal must be returned in writing 3. This notice should be passed on to all those who need to be aware within your organization. if you have further distributed the devices, please provide those Customers a copy of the recall notification and response form. 4. Confirm you have read and understood the recall instructions provided in the letter and submit the acknowledgment form.
Quantity in Commerce81,600 units
DistributionUS Nationwide distribution in the state of MD.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JTW
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