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FDA Medical Device Recalls (openFDA)

Becton Dickinson and Company: BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618

Recall number
Z-0672-2007
Recalling firm
Becton Dickinson and Company
Product
BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618
Status
Terminated
Initiated
2007-03-02
Posted
2007-03-29
Terminated
2008-03-05
Reason
Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)
Root cause
Other
Action
BD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.
Quantity
1500 units
Distribution
Nationwide.
Lot, serial or model codes
Lot Number: 6181868
510(k) numbers
not on file
PMA numbers
not on file
Product code
KYG
Firm FEI
1211998
Firm city
Waltham
Firm state
MA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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