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U.S. Department of Health and Human Services

Class 2 Device Recall Convenience Kit

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 Class 2 Device Recall Convenience Kitsee related information
Date Initiated by FirmSeptember 14, 2004
Date PostedOctober 28, 2004
Recall Status1 Terminated 3 on March 31, 2005
Recall NumberZ-0050-05
Recall Event ID 30119
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
ProductConvenience Kits containing Inject8 or Inject10 syringes.
Code Information Part No. K07-00116AP, Lot Nos A340949, A346191. Part No. K09-00302FP, Lot # A340485, A341488 Part No. K09-00579CP, Lot # A339214, A345673 Part No. K09-00585LP, Lot # A338201, A344694 Part No. K09-00759DP, Lot #A342359, A345674,   A347263. Part No. K09-00946MP, Lot # A341491 Part No. K09-00970K, Lot # A337245 Part No. K09-01574G, Lot # A343825 Part No. K09-01673H, Lot # A342676 Part No. K09-01908AP, Lot # A338729, A344187,   A344382. Part No. K09-02104HP, Lot # A337839, A346138 Part No. K09-02249H, Lot # A343819 Part No. K09-02249HP, Lot # A339688 Part No. K09-02334K, Lot # A345405 Part No. K09-02353G, Lot # A342675 Part No. K09-03242C, Lot # A342165 Part No. K09-03528D, Lot # A341710 Part No. K09-03978HP, Lot # A339229, A340896,  A344386. Part No.K09-04000HP, Lot # A338208, A339231,  A341504, A344612,  A341505, A341504. Part No. K09-04017C, Lot # A337857 Part No. K09-04316H, Lot # A342071. Part No. K09-04488A, Lot # A338228, A341118. Part No. K09-04863C, Lot # A337204, A338112. Part No. K09-04863C, Lot # A337204. Part No. K09-04923B, Lot # A340508, A 343196. Part No. K09-05138CP, Lot # A339425, A342802. Part No. K09-05229G, Lot # A339926. Part No. K09-05229GP, Lot # A345552. Part No. K09-05477A, Lot # A342803. Part No. K09-05785DP, Lot # A340897. Part No. K09-05939C, Lot # A337947, A342379. Part No. K09-05947D, Lot # A342670. Part No. K09-06262P, Lot # A341604. Part No. K09-07470C, Lot # A342173. Part No. K09-07547B, Lot # A340375. Part No. K09-07573AP, Lot # A344373. Part No. K09-07573P, Lot # A342349. Part No. K09-07589P, Lot # A347257, A347985. Part No. K09-07629CP, Lot # A344853. Part No. K09-07746A, Lot # A337319. Part No. K09-07759, Lot # A341614.  Part No. K09-07779P, Lot # A344855, A347876. Part No. K09-07847, Lot # A342385. Part No. K09-07883B, Lot # A336474. Part No. K09-07924AP, Lot # A346124. Part No. K09-07943AP, Lot # A345851. Part No. K09-07944A, Lot # A339427. Part No. K09-08020B, Lot # A331903. Part No. K09-08065P, Lot # A345570. Part No. K09-08150AP, Lot # A340352, A342387. Part No. K09-08214B, Lot # A340534 Part No. K09-08369, Lot # A342388. Part No. K09-08391AP, Lot # A340252, A343600. Part No. K09-08397, Lot # A335968. Part No. K09-90270KP, Lot # A3412623, A343596. Part No. K09-90358DP, Lot # A345692. Part No. K09-MS2366H, Lot # A341693. Part No. K09-MS2450B, Lot # A338759. Part No. K09-MS2550A, Lot # A343809. Part No. K09-MS2602A, Lot # A342813. Part No. K09-MS2638B, Lot # A341694, Part No. K09-MS2703B, Lot # A336929, A343808. Part No. K10-01223B, Lot # A339948. Part No. K10-03441P, Lot # A336328, A343551. Part No. K10-03616, Lot # A339959. Part No. K12-01176B, Lot # AS345883.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc
1600 Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-208-4405
Manufacturer Reason
for Recall		Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
FDA Determined
Cause 2		Other
ActionAll consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.
Quantity in Commerce143 kits
DistributionNationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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