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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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  Class 2 Device Recall BD see related information
Date Initiated by Firm May 25, 2022
Date Posted August 26, 2022
Recall Status1 Open3, Classified
Recall Number Z-1618-2022
Recall Event ID 90336
510(K)Number BK050036  K991702  K911731  K101502  K013971   
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983.
b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY8.5ML PLAS VACUTAINER (100/BX Model Number: 367988.
c. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 5MLPLAS VACUTAINER (100/BX) Model Number: 367986.
d. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY7.5ML PLAS VACUTAINER (100/BX) Model Number: 367987.
e. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY3.5ML PLAS VACUTAINER (100/BX Model Number: 367981.
f. BECTON DICKINSON BD Vacutainer TUBE, BLD COL PLAIN RED 10ML GLS VACUTAINER (100/BX 10BX/CS) Model Number: 366430.
g. BECTON DICKINSON BD Microtainer SST - Amber TUBE, CAPILLARY CLOT/SEP GLD 400/600UL PLAS MICROT (50/BX) Model Number: 365978.
h. BECTON DICKINSON BD Vacutainer CPT NC: 1.0mL FICOLL: 2.0mL TUBE, BLD CPT SOD CIT 8ML (60/CS) Model Number: BD 362761.
i. BECTON DICKINSON BD Vacutainer Rapid Serum Tube (RST) Thrombin TUBE, BLD COL CLOT ORG 5ML PETVACUTAINER (100/BX 10BX/CS) Model Number: 368774.
j. BECTON DICKINSON BD Vacutainer Buff. Na Citrate 0.109M, 3.2% TUBE, BLD COL SODCIT LTBLU 2.7ML PLAS VACUTAINER (100/BX) Model Number: 363083.
Code Information GTIN: a. 00382903679836; 50382903679831. b. 00382903679881; 50382903679886. c. 00382903679867; 50382903679862. d. 00382903679874; 50382903679879, e. 00382903679812; 50382903679817. f. 00382903664306; 30382903664307; 50382903664301. g. 00382903659784; 50382903659789. h. 00382903627615; 50382903627610. i. 00382903687749; 50382903687744. j. 00382903630837; 50382903630832.
Recalling Firm/
Manufacturer		 Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233
For Additional Information Contact Ms. Ruby Upadhyaya
804-553-2281
Manufacturer Reason
for Recall		 Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
FDA Determined
Cause 2		 Environmental control
Action Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. ¿ This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent possible patient harm. ¿ Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. ¿ Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
Quantity in Commerce a. 67 boxes b. 131 c. 51 d. 121 e. 2 f. 38 g. 16 h. 240 i. 17 j. 41
Distribution US Nationwide
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.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(K)s with Product Code = JKA and Original Applicant = BECTON DICKINSON & CO.
510(K)s with Product Code = JKA and Original Applicant = BECTON DICKINSON VACUTAINER SYSTEMS
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