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U.S. Department of Health and Human Services

Class 2 Device Recall Central Line Dressing Kit

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  Class 2 Device Recall Central Line Dressing Kit see related information
Date Initiated by Firm March 23, 2021
Create Date May 20, 2021
Recall Status1 Completed
Recall Number Z-1622-2021
Recall Event ID 87636
Product Classification Kit, surgical instrument, disposable - Product Code KDD
Product Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
Code Information Affected Lot Numbers: 400530 400528, 400536, 400537, 400514, 400522, 400514, 400514, 400522, 400514, 400569, 400569, 400565, 400569, 400565, 400556, 400556, 400556, 400540, 400562, 400537, 400530, 400537, 400530, 400537
Recalling Firm/
Manufacturer		 Bioseal Corporation
167 W Orangethorpe Ave
Placentia CA 92870-6922
For Additional Information Contact Customer service
800-441-7325
Manufacturer Reason
for Recall		 Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On 3/23/21, Bioseal emailed an "Urgent: Medical Device Recall" notice to affected consignees. In addition to informing consignees about the recall the firm ask consignees to take the following actions: 1. Please discontinue use of the product listed above. 2. Please complete enclosed response form listing the quantity of affected product on hand via email to recalls@biosealnet.com. Even if you do not have the affected product please complete and return the form. Once we have received the completed form we will forward product return information, if applicable. 3. If you have transferred possession of the product to another organization, you are required by FDA regulations to notify them of this recall communication. Please have any affected product returned to you for collection and return to Bioseal as specified above. 4. Adverse reactions or quality problems experience with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program. 5. If you have any questions regarding this matter, please contact customer service at 800-441-7325, Monday-Friday 8:00 AM - 5:00 PM P.S.T.
Quantity in Commerce 1,560 units
Distribution US: IL and MO OUS: None
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.
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