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Arrow Sheath Introducers
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Arrow Sheath Introducers Recall

Jul 26, 1994 |

Arrow Percutaneous Sheath Introducer Kits with Polyurethane  Sheath:
               (a)  Product No. AKO9801S;
               (b)  Product No. AK09810S;
               (c)  Product No. AK09810C;
               (d)  Product No. BD09880;
               (e)  Product No. CK01000;
               (f)  Product No. DS09850S;
               (g)  Product No. IC09880;
               (h)  Product No. MH09800;
               (i)  Product No. H09810VKS;
               (j)  Product No. NR09810S;
               (k)  Product No. PS09810S;
               (l)  Product No. S109880SE;
               (m)  Product No. SJ09805;
               (n)  Product No. SV09804;
               (o)  Product No. UT09880;
               (p)  Product No. WB09810S;
               (q)  Product No. CK01410;
               (r)  Product No. AK09817S;
               (s)  Product No. CA09886;
               (t)  Product No. LJ09807S;
               (u)  Product No. PH09806.  
Recall #Z-051/071-5.

CODE    Lot numbers: 
(a)  AK91084, AK91404;
 (b)  AK91574, AK90944, AK91294;
 (c)  AK90524; (d) B0664, B0664A;
 (e)  C1574; (f) D0384; (g) I1124;
 (h)  H1004, MH09800;  (i) M1004;
(j)  NR0874, NR1294; (k) S1364; (l) I1224;
 (m)  S1784; (n) S2913; (o) T1014, T1014A;
(p)  W1924; (q) C1784Z; (r) AK90804;
 (s)  C0604; (t) L1574; (u) P1294.

Arrow International, Inc., Randleman, North Carolina.

Arrow International, Inc., Reading, Pennsylvania, by  telephone beginning July 26, 1994, followed by letter July 28, 1994.  Firm-initiated recall ongoing.

DISTRIBUTION: Nationwide, Puerto Rico, Canada, Australia, Holland, Japan, United Kingdom.

QUANTITY: 20,905 units were distributed.

A process change, file number REV-3958, was initiated to reduce the amount of scrap from shrinkage of the hub.  This process change was not validated.  Inadequate luer lock connections between the sheath and hemostasis valve can  result in bleeding or air embolisms to occur. 

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