Merit Medical Systems, Inc: Convenience Kits containing Inject8 or Inject10 syringes.

Recall number

Z-0050-05

Recalling firm

Merit Medical Systems, Inc

Product

Convenience Kits containing Inject8 or Inject10 syringes.

Status

Terminated

Initiated

2004-09-14

Posted

2004-10-28

Terminated

2005-03-31

Reason

Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

Root cause

Other

Action

All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.

Quantity

143 kits

Distribution

Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

DQO

Firm FEI

1721504

Firm city

South Jordan

Firm state

UT

Firm country

not on file

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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